A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

Heart Failure Clinical Trial

— HERMES  

Official title:

HERMES: Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636176
• Other study ID #: EX6018-4915
• Secondary ID: U1111-1280-08102
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2023
• Est. completion date: July 2, 2027

Study information

• Verified date: March 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5600
• Est. completion date: July 2, 2027
• Est. primary completion date: July 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular
• At least one of the following:

1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.

2. Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.

• Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class II-IV).
• Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., myocardial infarction [MI] or heart failure [HF] hospitalisation).
• Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least

one of the following:

• Left atrial (LA) volume index greater than 34 milliliter per meter square (mL/m^2).
• LA diameter greater than equal to 3.8 centimeter (cm).
• LA length greater than equal to 5.0 cm.
• LA area greater than equal to 20 cm square.
• LA volume greater than equal to 55 milliters (mL).
• Intraventricular septal thickness greater than equal to 1.1 cm.
• Posterior wall thickness greater than equal to 1.1 cm.
• Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g/m^2 ) in men or greater than equal to 95 g/m^2 in women.
• E/e' (mean septal and lateral) greater than equal to 10.
• e' (mean septal and lateral) less than 9 centimeter per second (cm/s).
• No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2). Exclusion Criteria: Medical conditions - cardiovascular
• Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).
• Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
• Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
• Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
• Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
• Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).
• Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.
• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
• Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism). Medical conditions - infections/immunosuppression
• Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.

Related Conditions & MeSH terms

• Heart Failure
• Inflammation

Intervention

Drug:
• Ziltivekimab
Ziltivekimab 15 milligrams (mg) subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
• Placebo
Ziltivekimab placebo s.c. injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.

Locations

Country	Name	City	State
Argentina	DIM Clinica Privada	Buenos Aires
Argentina	Hospital Italiano	Buenos Aires
Argentina	CEMEDIC	Caba
Argentina	Fundacion Favaloro	Caba
Argentina	Fundacion Favaloro	Caba
Argentina	Mautalen Salud e investigación	Caba	Buenos Aires
Argentina	Instituto de Cardiología de Corrientes	Corrientes
Argentina	Centro de Investigaciones Clinica Baigorria	Granadero Baigorria	Santa Fe
Argentina	Centro de Investigaciones Médicas Clínica de Fracturas y Or	Mar del Plata
Argentina	Centro de Investigaciones Médicas Clínica de Fracturas y Or	Mar del Plata	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas	Mar del Plata
Argentina	Instituto de Investigaciones Clinicas San Nicolás	San Nicolás
Argentina	Centro de investigaciones Clinicas del Litoral	Santa Fe
Australia	Nightingale Research	Adelaide	South Australia
Australia	Royal Adelaide Hospital Cardiovascular Clinical Trials	Adelaide	South Australia
Australia	Flinders Medical Centre	Bedford Park	South Australia
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Concord Repatriation General Hospital - Cardiology	Concord	New South Wales
Australia	Frankston Hospital	Frankston	Victoria
Australia	The Canberra Hospital_Garran	Garran	Australian Capital Territory
Australia	Barwon Health (The Geelong Hospital)	Geelong	Victoria
Australia	Gosford Hospital	Gosford	New South Wales
Australia	Royal Hobart Hospital	Hobart	Tasmania
Austria	Krankenhaus St. Josef Braunau	Braunau
Austria	Krankenhaus St. Josef Braunau	Braunau
Austria	Medizinische Universität Graz	Graz
Austria	Fließer-Görzer [Ordination]	Saint Stefan
Austria	Fließer-Görzer [Ordination]	Saint Stefan
Austria	Uniklinikum Salzburg Kardiologie	Salzburg
Austria	Klinik Ottakring	Vienna
Austria	Medizinische Universität Wien	Vienna
Austria	Medizinische Universität Wien	Vienna
Austria	Imed 19- privat	Wien
Austria	Imed 19- privat	Wien
Austria	Klinik Favoriten	Wien
Belgium	OLV Ziekenhuis Aalst-Asse-Ninove	Aalst
Belgium	UZ Brussel	Brussel
Belgium	UZA - UZ Antwerpen - Cardiology Department	Edegem
Belgium	Ziekenhuis Oost-Limburg AV - Cardiology	Genk
Belgium	AZ Groeninge - Kortrijk - Cardiology	Kortrijk
Belgium	CHR de la Citadelle	Liège
Bosnia and Herzegovina	University Clinical Centre of the Republic Srpska	Banja Luka
Bosnia and Herzegovina	Dr. Abdulah Nakas General Hospital	Sarajevo
Bosnia and Herzegovina	University Clinical Centre Sarajevo	Sarajevo
Brazil	Jmf Clínica Do Coração Ltda	Aracaju
Brazil	CCIH-Consultoria em Controle de Infecção Hospitalar Ltda	Belo Horizonte	Minas Gerais
Brazil	Nucleo de Pesquisa Clinica do Hospital Vera Cruz	Belo Horizonte/MG
Brazil	Instituto de Pesquisa Clínica de Campinas	Campinas	Sao Paulo
Brazil	Loema Med e Bem Estar Centro Especializado em Cardiologia	Campinas	Sao Paulo
Brazil	PUCCAMP - Hospital e Maternidade Celso Pierro	Campinas	Sao Paulo
Brazil	Integral Pesquisa e Ensino	Cidade Nova Votuporanga	São Paulo
Brazil	Hospital de Clínicas da Universidade Federal de Goiânia	Goiânia/GO
Brazil	ICM - Instituto do Coração de Marília	Marília/SP
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Mãe de Deus - Porto Alegre	Porto Alegre/RS
Brazil	PROCAPE	Recife/PE
Brazil	Hospital das Clínicas de Ribeirão Preto	Ribeirão Preto/SP
Brazil	Hospital São Lucas Copacabana	Rio de Janeiro	RJ
Brazil	Instituto D'or de Pesquisa e Ensino	Rio de Janeiro
Brazil	CIP Centro Integrado de Pesquisas do Hospital de Base	São José do Rio Preto	Sao Paulo
Brazil	Universidade Federal de São Paulo - UNIFESP	São Paulo/SP
Brazil	Centro de Diag. e Pesquisa da Osteoporose do Espírito Santo	Vitória	Espirito Santo
Bulgaria	MHAT Hearth and brain EAD	Burgas
Bulgaria	Medical centre "Zdrave 1" OOD	Kozloduy
Bulgaria	Diagnostic Consulting Center 1- Lom EOOD	Lom
Bulgaria	"MHAT - UniHospital" OOD	Panagyurishte
Bulgaria	"Medical center Medconsult Pleven" OOD	Pleven
Bulgaria	UMHAT Heart and Brain	Pleven
Bulgaria	"UMHAT "Sveti Georgi" EAD	Plovdiv
Bulgaria	Medical centre Health Care OOD	Sandanski
Bulgaria	'Medical Center Hipokrena' EOOD	Sevlievo
Bulgaria	"Diagnostic - Consulting Center Aleksandrovska" EOOD	Sofia
Bulgaria	Diagnostic Consulting Center Ascendent	Sofia
Bulgaria	Medico-dental center ISUL - Tsaritsa Yoanna EOOD	Sofia
Bulgaria	MHAT "Knyaginya Klementina" -Sofia EAD	Sofia
Bulgaria	National Multiprofile Transport Hospital "Tsar Boris III"	Sofia
Bulgaria	"Medical center Zara-Med" EOOD	Stara Zagora
Bulgaria	MDHAT "Dr. Stephen Cherkezov" AD	Veliko Tarnovo
Canada	Viacar Recherche Clinique Inc.	Brossard	Quebec
Canada	University of Calgary_Calgary	Calgary	Alberta
Canada	Cambridge Cardiac Care Centre	Cambridge	Ontario
Canada	Saul Vizel Pro. Med. Corp	Cambridge	Ontario
Canada	Alta Clinical Research	Edmonton	Alberta
Canada	Dawson Clinical Research	Guelph	Ontario
Canada	Nova Scotia Health	Halifax	Nova Scotia
Canada	Hamilton Hlth Sc. - General Site	Hamilton	Ontario
Canada	St. Joseph's Hospital	London	Ontario
Canada	G.A. Research Associates Ltd.	Moncton	New Brunswick
Canada	Institut de Cardiologie de Montreal	Montreal	Quebec
Canada	CHU de Montréal	Montréal	Quebec
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Partnrs Adv Cardio Eval (PACE)	Newmarket	Ontario
Canada	North Shore Heart Centre	North Vancouver	British Columbia
Canada	North Shore Heart Centre	North Vancouver	British Columbia
Canada	North York Diagn & Cardiac Ctr	North York	Ontario
Canada	Centricity Research Oshawa	Oshawa	Ontario
Canada	Kawartha Cardiology Clinical Trials	Peterborough	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	CIUSSS de l'E CHUS_Sherbrooke	Sherbrooke	Quebec
Canada	CardioVasc HR Inc	St. Jean sur Richelieu	Quebec
Canada	Health Sciences North Rsrch Inst	Sudbury	Ontario
Canada	SMH Cardiology Clinical Trials Inc.	Surrey	British Columbia
Canada	CISSSL - Hôpital Pierre-Le Gardeur	Terrebonne	Quebec
Canada	Ctr de méd métab de Lanaudière	Terrebonne	Quebec
Canada	Diabetes Heart Research Centre	Toronto	Ontario
Canada	St. Michael's Hospital_Toronto	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
Canada	Diex Recherche Trois-Rivières	Trois-Rivières	Quebec
Canada	Ctr for Cardiovascular Innovation	Vancouver	British Columbia
Canada	St Pauls Hospital	Vancouver	British Columbia
Canada	Victoria Heart Institute Foundation	Victoria	British Columbia
Canada	Clinical Research Solutions Inc.	Waterloo	Ontario
Canada	CPS Research	Waterloo	Ontario
Canada	Winchester Dist Memorial Hosp	Winchester	Ontario
Canada	St. Boniface Hospital	Winnipeg	Manitoba
China	The First Hospital of Anhui University of Science &Technology (Huainan First People's Hospital)	Anhui/huainan
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Changsha Central Hospital	Changsha
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital, Yanghu Branch	Changzhou	Jiangsu
China	Changzhou No.2 People's Hospital, Yanghu Branch	Changzhou	Jiangsu
China	Chongqing University Three Gorges Hospital	Chongqing	Chongqing
China	Chongqing University Three Gorges Hospital	ChongQing	Chongqing
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy	Guangzhou	Guangdong
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Harbin Medical University	Ha Erbin
China	Hainan General Hospital	Haikou	Hainan
China	Hainan General Hospital	Haikou	Hainan
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Huai'an First People's Hospital, Nanjing Medical University	Huai'an	Jiangsu
China	Huashan Hospital Fudan University	Jingan/Shanghai
China	Lanzhou University Second Hospital_Internal Medicine-Cardiovascular Dept	Lanzhou	Gansu
China	Lishui People's Hospital	Lishui	Zhejiang
China	Lishui People's Hospital	Lishui	Zhejiang
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Zhongda Hospital, Southeast University	Nanjing
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning
China	Shanghai Xuhui Central Hospital	Shanghai
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Siping Central People's Hospital	Siping	Jilin
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Chest Hospital	Tianjin
China	The 1st Affiliated Hospital of WMU	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Colombia	Clinica de la Costa	Barranquilla
Colombia	Corazón IPS S.A.S	Barranquilla
Colombia	Fundacion del Caribe para la Investigacion Biomedica-BIOS	Barranquilla
Colombia	Fundacion del Caribe para la Investigacion Biomedica-BIOS	Barranquilla
Colombia	IPS Centro Cientifico Asistencial Jose Luis Accini SAS	Barranquilla	Atlántico
Colombia	Unidad de Estudios Clínicos de la Fundación Cardiovascular de Colombia	Bucaramanga-piedecuesta, Valle Del Menzuli - Santander	Santander
Colombia	Clinica Imbanco SAS	Cali
Colombia	IPS médicos Internistas de Caldas S.A.S.	Manizales	Caldas
Colombia	CardiovidCentro Cardiovascular Colombiano ClinicaSantaMaria	Medellin
Colombia	Hospital General de Medellin	Medellin	Antioquia
Colombia	Promotora Medica Las Americas S.A.	Medellin
Colombia	Rodrigo Botero S.A.S	Medellin	Antioquia
Colombia	Fundación Hospital Universidad del Norte	Soledad	Barranquilla
Colombia	Fundación Hospital Universidad del Norte	Soledad	Barranquilla
Croatia	Zupanijska bolnica Cakovec	Cakovec
Croatia	Opca bolnica Karlovac	Karlovac
Croatia	Opca bolnica Karlovac	Karlovac
Croatia	Specijalna bolnica Krapinske Toplice - Kardiologija	Krapinske Toplice	Krapinsko Zagorska County
Croatia	Clinical Hospital Centre Osijek	Osijek
Croatia	KBC Rijeka, Zavod za kardiomiopatije	Rijeka
Croatia	KBC Split	Split
Croatia	Clinical Hospital Dubrava	Zagreb	Grad Zagreb
Croatia	Poliklinika Aritmija	Zagreb	Grad Zagreb
Croatia	Poliklinika Magnolija	Zagreb
Croatia	Poliklinika Solmed	Zagreb	Grad Zagreb
Croatia	University Hospital Centre Zagreb	Zagreb	Grad Zagreb
Croatia	University Hospital Sveti Duh	Zagreb
Czechia	FN Hradec Kralove	Hradec Kralove
Czechia	KARDIOLOGIE - LIBEREC s.r.o.	Liberec
Czechia	Fakultni nemocnice Plzen - Lochotin	Plzen - Lochotín
Czechia	Policska nemocnice	Policka
Czechia	Kardiologická a interní ambulance	Praha 1
Czechia	Kardiologická a interní ambulance	Praha 1
Czechia	Fakultní poliklinika VFN ambulance Srdecniho selhani	Praha 2
Czechia	Nemocnice Slany Kardiologie	Slany
Czechia	Nemocnice Slany Kardiologie	Slany
Czechia	Vseobecna kardiologicka ambulance	Tabor
Czechia	Vseobecna kardiologicka ambulance	Tabor
Czechia	Kardiologie Trutnov Ferkl	Trutnov
Czechia	Clinical Trials Service s.r.o.	Uherske Hradiste
Czechia	Clinical Trials Service s.r.o.	Uherske Hradiste
Denmark	Aarhus Universitetshospital, Skejby Hjertesygdomme	Aarhus N
Denmark	Bispebjerg og Frederiksberg Hospital	Frederiksberg
Denmark	Herlev og Gentofte Hospital	Herlev	Region Hovedstaden
Denmark	Sjællands Universitetshospital_Roskilde	Roskilde
Denmark	Kardiologisk Odense & Svendborg	Svendborg	Region South
Estonia	East Tallinn Central Hospital	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	Tartu University Hospital	Tartu
Finland	HUS, Sydän- ja keuhkokeskus, kardiologian tutkimusyksikkö	HUS
Finland	StudyCor	Jyväskylä
Finland	Health Step Finland Oy	Kuopio
Finland	Seinäjoen keskussairaala	Seinäjoki
Finland	TAYS Sydänsairaala	Tampere
Finland	TYKS Sydänkeskus	Turku
France	Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1	La Tronche
France	Centre Hospitalier Universitaire de Montpellier-Hopital Arnaud de Villeneuve	Montpellier
France	Aphp-Hopital La Pitie Salpetriere-1	Paris
France	Aphp-Hopital Lariboisiere-1	Paris
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1	Toulouse
Germany	Universitaetsklinikum Aachen AöR	Aachen
Germany	Charite Universitatsmedizin Berlin KöR	Berlin
Germany	Charite Universitatsmedizin Berlin KöR	Berlin
Germany	Klinische Forschung Berlin GbR	Berlin
Germany	Kardiologisch-Angiologische Praxis Herzzentrum Bremen	Bremen
Germany	Kath. St. Paulus GmbH - St Johannes Hospital gGmbH	Dortmund
Germany	Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH	Dresden
Germany	Herzzentrum Dresden GmbH Universitätsklinik	Dresden
Germany	Zentrum fuer klinische Studien Suedbrandenburg GmbH	Elsterwerda
Germany	MVZ CCB Frankfurt Und Main-Taunus GbR	Frankfurt
Germany	Universitätsklinikum Frankfurt aM	Frankfurt am Main
Germany	Medical Center - University Of Freiburg	Freiburg
Germany	Justus Liebig University Giessen	Giessen
Germany	Universitaetsmedizin Goettingen	Göttingen
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Kardiologie Hassloch	Hassloch
Germany	UKS - Innere Medizin III	Homburg
Germany	University Hospital Jena KöR	Jena
Germany	Kardiopraxis Schirmer	Kaiserslautern
Germany	University of Leipzig	Leipzig
Germany	zero PRAXEN Mannheim-Schwetzingerstadt	Mannheim
Germany	LMU Klinikum München Klinik und Poliklinik 1	München
Germany	Dr. med. A. Wilke, Dr. med. A. Malazhavy und D. Lalev Denchev, Fachaerzte Innere Medizin und Kardiologie Partnerschaft	Papenburg
Germany	Al-Zoebi	Wermsdorf
Germany	Universitatsklinikum Wurzburg AöR	Würzburg
Greece	"Hygeia" General Hospital of Athens	Athens
Greece	"Sotiria" Thoracic Diseases Hospital of Athens	Athens
Greece	'G. Gennimatas' General Hospital of Athens	Athens
Greece	Alexandra General Hospital, Therapeutic Clinic	Athens	Attiki
Greece	Genl Hospital of Athens Ippokrateio,A' Cardiology Univ dpt	Athens
Greece	Hippokration Hospital	Athens
Greece	Iatriko Athinon (Athens Medical Canter)	Athens
Greece	Konstantopouleio G.H. of Athens, "Agia Olga"	Athens
Greece	U.G.H of Athens "Attikon"	Chaidari, Athens
Greece	General Hospital of Chios "Skilitsio"	Chios
Greece	Periphery University Hospital of Heraklion	Heraklion	Crete
Greece	Univ Gen Hospital Larisa, Internal Medicine Clinic	Larissa
Greece	Iatriko Athinon (Athens Medical Canter)	Pylea, Thessaloniki
Greece	General University Hospital of Patras	Rio Patras
Greece	"AHEPA" University General Hospital of Thessaloniki	Thessaloniki
Greece	"AHEPA" University General Hospital of Thessaloniki	Thessaloniki
Greece	'Ippokrateio' General Hospital of Thessaloniki	Thessaloniki
Greece	General Hospital of Thessaloniki 'G. Gennimatas	Thessaloniki
Hungary	EURÉKA-CENTER Orvosi és Szolgáltató Betéti Társaság	Baja
Hungary	Lausmed Kft.	Baja	Bács-Kiskun Vármegye
Hungary	Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés	Békéscsaba	Békés Megye
Hungary	Észak-Pesti Centrumkórház Honvédkórház	Budapest
Hungary	Gottsegen György Országos Kardiológiai Intézet	Budapest
Hungary	Jahn Ferenc Dél-pesti Kórház és Rendelointézet	Budapest
Hungary	Semmelweis Egyetem Városmajori Szív- és Érgyógyászat	Budapest
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy Megye
Hungary	Selye János Kórház	Komárom	Komárom-Esztergom
Hungary	Arina Trial Research Kft.	Orosháza	Békés Megye
Hungary	Coromed SMO Kft.	Pécs
Hungary	PTE ÁOK I. sz. Belgyógyászati Klinika	Pécs	Baranya Megye
Hungary	Szegedi Tudományegyetem II. sz Belgyógyászati és Kardiológia	Szeged	Csongrád-Csanád
Hungary	Léda Platán Magánklinika	Zalaegerszeg	Zala Megye
India	CIMS- Care Institute of Medical Sciences	Ahmedabad	Gujarat
India	Epic Hospital	Ahmedabad	Gujarat
India	Sardar Vallabhbhai Patel Institute of Medical Sciences and Research	Ahmedabad	Gujarat
India	Aligarh Muslim University	Aligarh
India	Manipal Hospital, Old Airport Road, Bengaluru	Bangalore	Karnataka
India	MS Ramaiah	Bengaluru
India	Narayana Institute of Cardiac Sciences, Bangalore	Bengaluru	Karnataka
India	Sri Jayadeva Institute of Cardiovascular Sciences & Research	Bengaluru	Karnataka
India	S.P. Medical College and A.G. Hospitals	Bikaner	Rajasthan
India	Post Graduate Institute of Medical Education & Research_Chandigarh	Chandigarh	Punjab
India	The Madras Medical Mission	Chennai	Tamil Nadu
India	Amrita Institute of Medical Sciences	Cochin	Kerala
India	Shri Mahant Indiresh Hospital	Dehradun	Uttarakhand
India	Lalitha Super Specialities Hospital	Guntur	Andhra Pradesh
India	Lalitha Super Specialities Hospital	Guntur	Andhra Pradesh
India	Medanta - The Medicity Multi-Speciality Hospital, Gurugram	Gurugram	Haryana
India	GNRC Hospital	Guwahati	Assam
India	AIG Hospitals,Hyderabad	Hyderabad	Telangana
India	Guru Nanak CARE Hospitals	Hyderabad	Telangana
India	Osmania General Hospital	Hyderabad	Telengana
India	SMS Medical College & Attached Hospitals	Jaipur	Rajasthan
India	All India Institute of Medical Sciences (AIIMS)	Jodhpur	Rajasthan
India	All India Institute of Medical Sciences (AIIMS), Jodhpur	Jodhpur	Rajasthan
India	KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre	Karnataka
India	Lisie Hospital	Kochi	Kerala
India	IPGME&R and SSKM Hospital	Kolkata	West Bengal
India	Government Medical College, Kozhikode	Kozhikode	Kerala
India	King George's Medical University (KGMU)	Lucknow	Uttar Pradesh
India	Dayanand Medical College & Hospital	Ludhiana	Punjab
India	Deep Hospital	Ludhiana	Punjab
India	Fortis Hospital, Mohali	Mohali	Punjab
India	Seth GS medical college and KEM Hospital	Mumbai	Maharashtra
India	Arneja Heart & Multispeciality Hospital	Nagpur	Maharashtra
India	Government Medical College and Super Speciality Hospital, Nagpur	Nagpur	Maharashtra
India	Sengupta Hospital and Research Institute	Nagpur	Maharashtra
India	Shri Krishna Hrudayalaya & Critical Care Centre	Nagpur	Maharashtra
India	VMMC & Safdarjung Hospital	New Dehli	New Delhi
India	Aakash Healthcare Super Speciality Hospital	New Delhi
India	All India Institute of Medical Sciences (AIIMS)	New Delhi	Delhi
India	Dr B L Kapur Memorial Hospital	New Delhi
India	Fortis Escorts Heart Institute, New Delhi	New Delhi	Delhi
India	G B Pant Institute of Postgraduate Medical Education and Research	New Delhi	Delhi
India	Sir Ganga Ram Hospital-Cardiology	New Delhi
India	Lakshmi Hospital	Palakkad
India	JIPMER	Puducherry
India	B J Goverment Medical College and Sassoon General Hospital	Pune	Maharashtra
India	Jehangir Clinical Development Centre	Pune	Maharashtra
India	KEM Hospital	Pune	Maharashtra
India	Sahyadri Clinical Research And Development Center	Pune	Maharashtra
India	Nirmal Hospital Pvt. Ltd.	Surat	Gujarat
India	Shri B. D. Mehta Mahavir Heart Institute	Surat	Gujarat
India	Rhythm Heart Institute	Vadodara	Gujarat
India	Ramesh Hospitals	Vijayawada	Andhra Pradesh
India	Siddhartha Medical College & Government General Hospital	Vijaywada	Andhra Pradesh
Ireland	Cork University Hospital	Cork
Ireland	Mater Miscericordiae Hospital	Dublin
Ireland	Mater Private Network - Dublin	Dublin
Ireland	St James's CRF	Dublin	Leinster
Ireland	The Heartbeat Trust	Dublin
Ireland	Mater Private Network Cork	Mahon, Cork
Israel	Heart failure unit Rambam Medical center	Haifa
Israel	Hadassah Ein Kerem MC - Cardio	Jerusalem
Israel	Heart Failure Unit, Rabin Medical Center - Beilinson Campus	Petah-Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Cardio Vascular Research Center Sourasky MC	Tel Aviv
Israel	Sheba Medica Center - Clinical Research Unit	Tel Hashomer
Israel	Shamir (Assaf Harofe) Medical Center	Zrifin
Italy	AORN "San Pio"- Benevento	Benevento	Bn
Italy	ASST Papa Giovanni XXIII	Bergamo	Bg
Italy	Spedali Civili Brescia	Brescia	Bs
Italy	Ospedale Santo Spirito	Casale Monferrato	Al
Italy	AORN "Sant'Anna e San Sebastiano"	Caserta	Ce
Italy	Azienda Ospedaliero-Universitaria Renato Dulbecco	Catanzaro	Cz
Italy	A.O.U. Ferrara, Sant'Anna	Cona (Ferrara)	Fe
Italy	A.O.U. Ferrara, Sant'Anna	Cona (Ferrara)	Fe
Italy	Ospedali riuniti di Foggia	Foggia
Italy	IRCCS Azienda Ospedaliero Universitaria San Martino - IST	Genova	Ge
Italy	ASST Fatebenefratelli Ospedale Luigi Sacco Medicina Interna	Milano
Italy	Azienda Ospedaliera San Gerardo	Monza
Italy	Azienda Ospedaliera di Rilievo Nazionale AORN Dei Colli, "V.Monaldi",	Napoli
Italy	Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara	Novara
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser	Perugia	Pg
Italy	Fondazione CNR-Regione Toscana Gabriele Monasterio	Pisa	Pi
Italy	Fondazione CNR-Regione Toscana Gabriele Monasterio	Pisa	Pi
Italy	Presidio Ospedaliero di Rivoli	Rivoli	To
Italy	Ospedale San Filippo Neri	Roma	Rm
Italy	Azienda Ospedaliera Universitaria Senese	Siena	Si
Italy	Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia	Torino	To
Italy	Azienda Sanitaria Ospedaliera Ordine Mauriziano SC Cardiologia	Torino	To
Italy	Azienda Sanitaria Univ Giuliano Isontina	Trieste
Italy	Azienda Sanitaria Univ Giuliano Isontina	Trieste
Italy	AOUI Verona	Verona	Vr
Italy	AOUI Verona	Verona	Vr
Japan	The Univ. of Tokyo Hp., Dept. of Cardiovascular Medicine	Bunkyo-ku, Tokyo
Japan	Hamanomachi Hospital_Cardiovascular medicine	Fukuoka
Japan	Kyushu University Hospital_Cardiovascular Medicine	Fukuoka
Japan	Kyushu University Hospital_Cardiovascular Medicine	Fukuoka
Japan	Fukuoka University Hospital_Cardiology	Fukuoka-shi, Fukuoka
Japan	Ogaki Municipal Hospital_Cardiology	Gifu
Japan	JA Shizuoka Kohseiren Enshu Hospital_ cardiology	Hamamatsu-shi, Shizuoka
Japan	Hyogo Prefectural HarimaHimeji General Medical Center_Cardiology	Himeji-shi, Hyogo
Japan	Asahikawa-Kosei General Hospital_Cardiology	Hokkaido
Japan	Veritas Hospital_Cardiology	Hyogo
Japan	National Hospital Organization Mito Medical Center_Cardiovascular medicine	Ibaraki
Japan	Saiseikai Imabari Hospital	Imabari-shi, Ehime
Japan	Ishikawa Prefectural Central Hospital_Cardiology	Ishikawa
Japan	Ishikawa Prefectural Central Hospital_Cardiology	Ishikawa
Japan	Mitoyo General Hospital_Cardiovascular medicine	Kagawa
Japan	Kagoshima City Hospital_Cardiovascular Medicine	Kagoshima
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center_Cardiology	Kanagawa
Japan	Kanagawa Prefectural Hospital Organization Kanagawa Cardiovascular and Respiratory Center_Cardiology	Kanagawa
Japan	Tokai University Hospital_Cardiology	Kanagawa
Japan	Yokohama Minami Kyousai Hospital_Cardiology	Kanagawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada-shi, Osaka
Japan	Japan Community Health care Organization Kyushu Hospital_Cardiology	Kitakyushu-shi, Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Rakuwakai Marutamachi Hospital_Cardiology	Kyoto
Japan	Mie Prefectural General Medical Center_Cardiology	Mie
Japan	KKR Tohoku Kosai Hospital_Cardiology	Miyagi
Japan	National Hospital Organization Sendai Medical Center_Cardiovascular medicine	Miyagi
Japan	Tohoku Medical and Pharmaceutical University Hospital_Division of Cardiology	Miyagi
Japan	Iwate Prefectural Central Hospital	Morioka-shi, Iwate
Japan	Nagasaki Harbor Medical Center_Cardiovascular medicine	Nagasaki
Japan	Okayama City General Medical Center Okayama City Hospital_Cardiovascular Medicine	Okayama
Japan	Okayama Medical Center	Okayama
Japan	Okayama University Hospital_Cardiovascular Medicine	Okayama-shi, Okayama
Japan	Okayama University Hospital_Cardiovascular Medicine	Okayama-shi, Okayama
Japan	National Cerebral and Cardiovascular Center Hospital_Department of Heart Failure	Osaka
Japan	National Hospital Organization Osaka National Hospital_Cardiovascular Division	Osaka
Japan	Osaka University Hospital_Cardiovascular medicine	Osaka
Japan	Saiseikai Suita Hospital_Cardiovascular Medicine	Osaka
Japan	Yao Tokushukai General Hospital	Osaka
Japan	Saga-ken Medical Centre Koseikan_Cardiology	Saga
Japan	Chutoen General Medical Center_Cardiology	Shizuoka
Japan	Kagawa Prefectural Central Hospital, Cardiovascular Medicine	Takamatsu-shi, Kagawa
Japan	Juntendo University Hospital_Cardiology	Tokyo
Japan	Keio University Hospital_Cardiology	Tokyo
Japan	Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Tokyo
Japan	Tottori University Hospital_Cardiovascular Medicine	Tottori
Japan	Toyama University Hospital_Internal Medicine 2	Toyama
Japan	Uwajima City Hospital_ Cardiology	Uwajima-shi, Ehime	Ehime, Uwajima-shi
Japan	Japan Community Health care Organization Tokuyama Community Health Center_Department of Cardiology	Yamaguchi
Japan	National Hospital Organization Iwakuni Clinical Center_Cardiovascular Medicine	Yamaguchi
Japan	Showa University Fujigaoka Hospital_Cardiology	Yokohama	Kanagawa
Japan	Saiseikai Yokohamashi Nanbu Hospital_Cardiology	Yokohama-shi, Kanagawa
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju
Latvia	Zemgales diabetes centre	Jelgava
Latvia	Adoria	Riga
Latvia	GK Neiroklinika	Riga
Latvia	P. Stradins Clinical University Hospital	Riga
Latvia	Riga 1st Hospital	Riga
Latvia	Riga East Clinical University Hospital - Clinic "Gailezers"	Riga
Lithuania	JSC "Saules seimos medicinos centras"	Kaunas
Lithuania	Klinikiniai sprendimai, Kaunas	Kaunas
Lithuania	Klaipeda university hospital	Klaipeda
Lithuania	Republican Siauliai Hospital Consulting Outpatient Clinic	Siauliai
Lithuania	JSC Inlita Santaros	Vilnius
Lithuania	Vilnius University hospital Santaros klinikos	Vilnius
Malaysia	Hospital Sultanah Bahiyah	Alor Setar
Malaysia	Hospital Universiti Kebangsaan Malaysia	Cheras	Kuala Lumpur
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan
Malaysia	Sarawak Heart Centre	Kota Samarahan	Sarawak
Malaysia	Hospital Universiti Kebangsaan Malaysia	Kuala Lumpur
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan	Pahang
Malaysia	Universiti Teknologi MARA, Sungai Buloh Campus	Sungai Buloh	Selangor
Mexico	Hospital Cardiológica Aguascalientes	Aguascalientes	Ags
Mexico	Hospital Cardiológica Aguascalientes	Aguascalientes	Ags
Mexico	Instituto Nacional de Cardiología Ignacio Chavez	Ciudad de Mexico	México, D.F.
Mexico	Centro para el Desarrollo de la Medicina y la Asistencia	Culiacán	Sinaloa
Mexico	Diseño y Planeacion en Investigacion Medica S.C.	Guadalajara	Jalisco
Mexico	Centro de Investigación Biomédica y Farmacéutica S.C.	Mexico City
Mexico	Cardiolink Clin Trials S.C.	Monterrey	Nuevo Leon
Mexico	Cardiolink Clin Trials S.C.	Monterrey	Nuevo Leon
Mexico	Eukarya Pharmasite S.C.	Monterrey	Nuevo Leon
Mexico	Internal Medicine Clin Trials	Monterrey	Nuevo León
Mexico	Centro de atención e investigación cardiovascular del Potosí	San Luis Potosí	San Luis Potosi
Mexico	Centro de Investigación y Control Metabólico S. C.	San Nicolas de los Garza	NL
Mexico	Centro de Estudios Clinicos de Querétaro S.C.	Santiago De Querétaro, Qro.	Querétaro
Mexico	Centro de Estudios Clinicos de Querétaro S.C.	Santiago De Querétaro, Qro.	Querétaro
Mexico	CINCAME	Tijuana	Baja California
Mexico	Hospital Angeles de Xalapa	Xalapa	Veracruz
Mexico	Hospital Angeles de Xalapa	Xalapa	Veracruz
Netherlands	OLVG Oost	Amsterdam
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Albert Schweitzer Ziekenhuis locatie Dordwijk	Dordrecht
Netherlands	Treant zorggroep	Emmen
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	UMC Groningen	Groningen
Netherlands	Zuyderland ziekenhuis	Heerlen
Netherlands	Maastricht Universitair Medisch Centrum	Maastricht
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus MC	Rotterdam
North Macedonia	PHI City General Hospital 8th September	Skopje
North Macedonia	PHI University Clinic for Cardiology	Skopje
Norway	Haukeland Universitetssykehus	Bergen
Norway	Akershus universitetssykehus HF	Lørenskog
Norway	Colosseumklinikken Medisinske Senter AS	Oslo
Norway	Oslo universitetssykehus HF - Ullevål	Oslo
Norway	Rikshospitalet - Kardiologisk forskning	Oslo
Norway	Stavanger Universitetssykehus, Helse Stavanger HF	Stavanger
Poland	American Heart of Poland S.A.	Belchatow	Lodzkie
Poland	American Heart of Poland S.A.	Belchatow
Poland	Panek Med Centrum Leczenia Chorob Naczyn	Bialystok	Podlaskie Voivodeship
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio	Bialystok	Podlaskie
Poland	American Heart of Poland S.A.	Chrzanów	Malopolskie
Poland	MediNess Sp. z o.o.	Cracow	Malopolskie
Poland	MediNess Sp. z o.o.	Cracow	Malopolskie
Poland	American Heart of Poland S.A.	Dabrowa Górnicza	Slaskie
Poland	Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman	Gdynia
Poland	Samodzielny Publiczny Specjalistyczny Szpital Zachodni Im.Sw.Jana Pawla II	Grodzisk Mazowiecki
Poland	Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Silesian Voivodeship
Poland	Pro Familia Altera Sp. z o.o.	Katowice	Slaskie
Poland	Specjalistyczna Praktyka Lekarska L. Bryniarski	Krakow
Poland	UniCardia & UniMedica & UniEstetica	Krakow
Poland	Instytut Centrum Zdrowia Matki Polki	Lodz
Poland	Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow	Lodz	Lodzkie
Poland	Wojewódzki Specjalistyczny Szpital im.Wl. Bieganskiego,	Lodz
Poland	Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu	Przemysl
Poland	Aka-Med Centrum	Ruda Slaska	Silesian Voivodeship
Poland	American Heart of Poland S.A.	Sztum
Poland	Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Kuyavian-Pomeranian Voivodeship
Poland	American Heart of Poland S.A.	Tychy	Slaskie
Poland	Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego Centrum Medycznego Ksztalcenia Podyplomowego	Warszawa	Mazowieckie
Poland	Wojskowy Instytut Medyczny	Warszawa
Poland	Praktyka Lekarska-Tomasz Borkowski	Wloclawek	Kujawsko-pomorskie
Poland	4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu	Wroclaw	Dolnoslaskie
Poland	Uniwersytecki Szpital Kliniczny im. J.Mikulicza-Radeckiego	Wroclaw	Dolnoslaskie
Poland	Zdrowie S.C. Agnieszka I Donald Drozdz	Wroclaw	Dolnoslaskie
Poland	Slaskie Centrum Chorob Serca W Zabrzu	Zabrze	Slaskie
Poland	American Heart of Poland S.A.	Zgierz	Lódz Voivodeship
Portugal	CHTâmega e Sousa - Hospital Padre Américo	Guilhufe - Penafiel
Portugal	Centro Hospitalar Lisboa Norte	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	CHLO, EPE - Hospital São Francisco Xavier	Lisbon
Portugal	Centro Hospitalar do Porto, E.P.E	Porto
Portugal	Centro Hospitalar de Setubal	Setubal
Romania	Cabinet Medical de Cardiologie Dr. Calin Pop	Baia Mare
Romania	Spitalul Jude?ean de Urgen?a Braila	Braila
Romania	Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed	Brasov
Romania	Davius Clinicmed Srl	Bucharest
Romania	Centrul Medical Emerald	Bucuresti
Romania	Donna Medplus S.R.L.	Bucuresti
Romania	Ecocard Srl	Bucuresti
Romania	Ecocard Srl	Bucuresti
Romania	Hightech Medical Services S.R.L.	Bucuresti
Romania	Lotus Med SRL	Bucuresti
Romania	Spitalul Clinic de Urgenta "Sf. Ioan" Bucuresti	Bucuresti
Romania	Spitalul Universitar de Urgen?a Elias	Bucuresti
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucuresti
Romania	Mat Cord Biomedica S.R.L.	Buzau
Romania	Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta	Constanta
Romania	Cardiomed SRL	Craiova
Romania	Neurocord Medical SRL	Craiova
Romania	Neurocord Medical SRL	Craiova
Romania	SC Diamed Obesity SRL	Galati
Romania	Institutul de Boli Cardiovasculare "Prof. Dr. George I.M. Georgescu"	Iasi
Romania	SC Cardiomed SRL	Iasi
Romania	SC Consultmed SRL	Iasi
Romania	Bella Praxis S.R.L.	Pascani
Romania	Sc Sal Med Srl	Pitesti
Romania	Spitalul Clinic Judetean De Urgenta Targu Mures	Targu Mures
Romania	Spitalul Clinic Municipal de Urgenta Timisoara	Timi?oara
Romania	Institutul de Boli Cardiovasculare Timisoara	Timisoara
Romania	CMI Dr. Cristian Podoleanu	Tirgu Mures	Targu Mures
Serbia	Clinical centre of Serbia, Clinic for cardiology	Belgrade
Serbia	Clinical Centre of Serbia, Emergency Centre, Department of Cardiology	Belgrade
Serbia	Clinical Hospital Center Bezanijska Kosa	Belgrade
Serbia	Clinical Hospital Centre Zemun	Belgrade
Serbia	Emergency Internal Medicine Clinic	Belgrade
Serbia	Institute for Cardiovascular Diseases ''Dedinje''	Belgrade
Serbia	University Clinical Centre Kragujevac	Kragujevac
Serbia	University Clinical Centre Nis, Clinic for Cardiology	Nis
Serbia	Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica	Sremska Kamenica
Singapore	Changi General Hospital	Singapore
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	National Heart Centre Singapore	Singapore
Singapore	National University Hospital Singapore	Singapore
Singapore	Sengkang General Hospital	Singapore
Slovakia	KARDIO-SANUS, spol. s r.o.	Bratislava
Slovakia	Narodny ustav srdcovych a cievnych chorob, a.s.	Bratislava
Slovakia	Nemocnica S Poliklinikou Brezno N.O.	Brezno	Banskobystricky Kraj
Slovakia	CARDIO D&R, s.r.o.	Kosice
Slovakia	Intradia s.r.o.	Nitra
Slovakia	Interna SK s.r.o.	Svidnik	Presovsky Kraj
Slovakia	Fakultna Nemocnica Trnava	Trnava
Slovakia	MEDIVASA, s.r.o., Kardiologicka ambulancia 1, 2	Zilina
Slovenia	General hospital Celje - cardiology	Celje
Slovenia	UKC Ljubljana, Cardiology department	Ljubljana
Slovenia	UKC Maribor - cardiology	Maribor
South Africa	Cardiology Research_Bloemfontein	Bloemfontein	Free State
South Africa	IATROS International	Bloemfontein	Free State
South Africa	Cardiac Clinical Research Unit, University of Cape Town	Cape Town	Western Cape
South Africa	Dr Corbett	Cape Town	Western Cape
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape
South Africa	Synexus Helderberg Clinical Research Centre	Cape Town	Western Cape
South Africa	Tiervlei Trial Centre	Cape Town	Western Cape
South Africa	Tread Research (Pty)Ltd	Cape Town	Western Cape
South Africa	Johese Clinical Research	Centurion	Gauteng
South Africa	KwaPhila Health Solutions	Durban	KwwaZulu Natal
South Africa	Excellentis Clinical Trial Consultants	George	Eastern Cape
South Africa	Dr Garda Cardiology Practice	Johannesburg	Gauteng
South Africa	Wits Bara Clinical Trial Site	Johannesburg	Gauteng
South Africa	WITS Clinical Research	Johannesburg	Gauteng
South Africa	Lenasia Clinical Trial Centre	Lenasia	Gauteng
South Africa	Dr Hendrik Snyman's Practice	Mossel Bay	Western Cape
South Africa	Dr Mpe's Practice	Pretoria	Gauteng
South Africa	Raslouw Private Hospital	Pretoria	Gauteng
South Africa	RYEXO Clinical Research	Pretoria	Gauteng
South Africa	RYEXO Clinical Research	Pretoria	Gauteng
South Africa	Synexus Watermeyer Clinical Research Centre	Pretoria	Gauteng
South Africa	Clinical Projects Research	Worcester	Western Cape
South Africa	Clinical Projects Research	Worcester	Western Cape
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Bellvitge	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Madrid
Spain	Clínica Nuevas Tecnologías en Diabetes y Endocrinología	Sevilla
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung city
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Taipei Medical University Hospital	Taipei city
Taiwan	Chang Gung Medical Foundation - Linkou Branch	Taoyuan city
Thailand	Cardio-Vajira	Bangkok
Thailand	Cardio-Vajira	Bangkok
Thailand	Chulabhorn hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Ramathibodi Hospital-Cardiovascular metabolic Center	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Songklanagarind Hospital	Hat Yai	Songkla
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	Thammasat University Hospital	Klong Luang, Pathumthani	Pathumthani
Thailand	Sunpasitthiprasong Hospital	Ubon Ratchathani
Turkey	Afyonkarahisar Health Sciences University	Afyon
Turkey	Afyonkarahisar Health Sciences University	Afyon
Turkey	Hacettepe University Medical Faculty_Ankara	Ankara
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Akdeniz University Medical Faculty	Antalya
Turkey	Trakya University	Edirne
Turkey	Eskisehir Osmangazi University-Cardio	Eskisehir
Turkey	Dr. Siyami Ersek Gogus Kalp ve Damar Cerrahisi EAH	Istanbul
Turkey	Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training Research Hospital_Istanbul	Istanbul
Turkey	Dokuz Eylul University School of Medicine, Cardiology	Izmir
Turkey	Ege University School of Medicine, Cardiology Department	Izmir
Turkey	Erciyes University Cardiology	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi Hastanesi	Kocaeli
Turkey	Mersin University Cardiology	Mersin
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	University Hospital Monklands	Airdrie	Lanarkshire
United Kingdom	Basildon University Hospital	Basildon	Essex
United Kingdom	Basildon University Hospital	Basildon	Essex
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Southmead Hospital	Bristol
United Kingdom	St. Richards Hospital	Chichester	West Sussex
United Kingdom	Craigavon Area Hospital	Craigavon
United Kingdom	Royal Bournemouth Hospital	Dorest
United Kingdom	Royal Bournemouth Hospital	Dorset
United Kingdom	University Hospital Hairmyres	East Kilbride	South Lanarkshire
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust	Exeter
United Kingdom	Royal Devon University Healthcare NHS Foundation Trust	Exeter
United Kingdom	Glasgow Clinical Research Facility	Glasgow
United Kingdom	Wycombe General Hospital	High Wycombe
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Manchester Royal Infirmary_Manchester_0	Manchester
United Kingdom	North Tyneside General Hospital	North Shields
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	University of North Tees Hospital	Stockton-on-Tees
United Kingdom	University of North Tees Hospital	Stockton-on-Tees
United Kingdom	St George's Hospital	Tooting	London
United Kingdom	St George's Hospital	Tooting	London
United States	Capital Cardiology Associates_Albany	Albany	New York
United States	Advanced Cariodvascular LLC	Alexander City	Alabama
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Heart MD_Allen TX	Allen	Texas
United States	PharmaTex Research, LLC	Amarillo	Texas
United States	University of Michigan Medicine	Ann Arbor	Michigan
United States	Northwest Heart Clinical Research, LLC	Arlington Heights	Illinois
United States	Emory University School of Medicine_Atlanta	Atlanta	Georgia
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Rocky Mountain Regional VAMC	Aurora	Colorado
United States	Austin Heart	Austin	Texas
United States	Ascension Saint Agnes Heart Ca	Baltimore	Maryland
United States	Johns Hopkins University_Baltimore	Baltimore	Maryland
United States	National Heart Institute Cal	Beverly Hills	California
United States	LOUISIANA HEART Center	Bogalusa	Louisiana
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Advanced Heart Care LLC	Bridgewater	New Jersey
United States	Chear Center LLC	Bronx	New York
United States	University at Buffalo_Erie County Med Ctr	Buffalo	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Capital Area Cardio Assoc	Camp Hill	Pennsylvania
United States	Penn State Hlth Holy Spirit Med Ctr	Camp Hill	Pennsylvania
United States	Aultman Hospital	Canton	Ohio
United States	UNC Cardiology Outpatient Ctr	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	James River Cardiology	Chesterfield	Virginia
United States	Prisma Health-Midlands	Columbia	South Carolina
United States	Valley Clinical Trials	Covina	California
United States	Nature Coast Clin Rsrch_Crystal River	Crystal River	Florida
United States	UTD SW Medical Center-Dallas	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Detroit Med Center-Wayne State	Detroit	Michigan
United States	Henry Ford Hlth System_Detroit	Detroit	Michigan
United States	Advocate Good Samaritan	Downers Grove	Illinois
United States	Dallas Heart and Vascular	Duncanville	Texas
United States	Duke University	Durham	North Carolina
United States	David Turbay, MD, PLLC	El Paso	Texas
United States	Baptist Health_Elizabethtown	Elizabethtown	Kentucky
United States	Midwest Cardiovascu Rsrch Foundation	Elkhart	Indiana
United States	Heart House_Elmer	Elmer	New Jersey
United States	Eastern Shore Rsrch Inst, LLC	Fairhope	Alabama
United States	Virginia Heart	Falls Church	Virginia
United States	Elite Research Center	Flint	Michigan
United States	Integrative Research Assoc Inc	Fort Lauderdale	Florida
United States	Healthy Heart Cardiology	Grand Rapids	Michigan
United States	Medication Mgmnt, LLC_Grnsboro	Greensboro	North Carolina
United States	Asha Clinical Rsch-Munster, LLC	Hammond	Indiana
United States	Heart Clinic of Hammond	Hammond	Louisiana
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Chicago Medical Research LLC	Hazel Crest	Illinois
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Memorial Region Hosp_Hollywood	Hollywood	Florida
United States	The Queen's Medical Center	Honolulu	Hawaii
United States	Biopharma Informatic_Houston	Houston	Texas
United States	Cardiovasc Spec of Willowbrook	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Texas Heart Inst Medical Ctr	Houston	Texas
United States	UT Physicians - Houston Medical Center	Houston	Texas
United States	Heart Center Rsrch_Hunstville	Huntsville	Alabama
United States	Franciscan Network-IN Heart PHY	Indianapolis	Indiana
United States	University Of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Apex Research Foundation, LLC	Jackson	Tennessee
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	E Coast Inst for Rsrch LLC_Jacksonville	Jacksonville	Florida
United States	Jacksonville Ctr for Clin Res	Jacksonville	Florida
United States	NSC Research, Inc	Johns Creek	Georgia
United States	Logan Health Research	Kalispell	Montana
United States	Marian David, MD, PC	Kew Gardens	New York
United States	Tennova Healthcare-Turkey Creek Medical Center	Knoxville	Tennessee
United States	Scripps Memorial Hospital La Jolla	La Jolla	California
United States	Purushotham & Akther Kotha MD, inc.	La Mesa	California
United States	Heart Grp_ Lancaster Gen Hlth	Lancaster	Pennsylvania
United States	Capitol Cardiology Assoc_Lanham	Lanham	Maryland
United States	Witham Health Services	Lebanon	Indiana
United States	The Research Group of Lexington LLC	Lexington	Kentucky
United States	NJ Heart	Linden	New Jersey
United States	NJ Heart	Linden	New Jersey
United States	Cardiology & Medicine Clinic	Little Rock	Arkansas
United States	S Denver Cardiology Associates	Littleton	Colorado
United States	Barnabas Health	Livingston	New Jersey
United States	VA Loma Linda Hlthcr Sys	Loma Linda	California
United States	VA Greater Los Angeles Hlthcare System	Los Angeles	California
United States	Baptist Health Louisville	Louisville	Kentucky
United States	Robley Rex VA Medical Center	Louisville	Kentucky
United States	University Of Louisville	Louisville	Kentucky
United States	Duke University/Southeastern	Lumberton	North Carolina
United States	Duke University/Southeastern	Lumberton	North Carolina
United States	GA Arrhythmia Cons & Rsch Inst	Macon	Georgia
United States	William S Middleton Mem VA Hosp	Madison	Wisconsin
United States	Carient Heart and Vascular	Manassas	Virginia
United States	Fairview Health Services	Maplewood	Minnesota
United States	Fairview Health Services	Maplewood	Minnesota
United States	Rama Research LLC	Marion	Ohio
United States	Texas Institute of Cardiology PA	McKinney	Texas
United States	St. Luke's Idaho Cardiology Associates	Meridian	Idaho
United States	Amavita Research Services, LLC	Miami	Florida
United States	Baptist Health South Florida	Miami	Florida
United States	Pioneer Clinical Studies	Miami	Florida
United States	Aurora St. Luke's Medical Centr	Milwaukee	Wisconsin
United States	Minneapolis VA Health Care Sys	Minneapolis	Minnesota
United States	Carteret Medical Group	Morehead City	North Carolina
United States	WVU Heart & Vascular Institute	Morgantown	West Virginia
United States	Inspira Health	Mullica Hill	New Jersey
United States	Cardiovascular Rsrch of NW_IN	Munster	Indiana
United States	CIS Research _Naperville	Naperville	Illinois
United States	NCH Research Institute	Naples	Florida
United States	University Medical Center New Orleans	New Orleans	Louisiana
United States	Harlem Cardiology_Madison ave	New York	New York
United States	Mount Sinai Hosp at NYC	New York	New York
United States	Mount Sinai Hosp at NYC	New York	New York
United States	NY Presbyt Hosp-W Cornell Med	New York	New York
United States	Saint Michael's Med Ctr NJ	Newark	New Jersey
United States	Saint Michael's Med Ctr NJ	Newark	New Jersey
United States	Sentara Clinical Research	Norfolk	Virginia
United States	York Clinical Research LLC	Norfolk	Virginia
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Ocala Cardiovascular Research	Ocala	Florida
United States	South Oklahoma Heart Research, LLC	Oklahoma City	Oklahoma
United States	Univ. of Nebraska Medical Center_Omaha	Omaha	Nebraska
United States	UCI Health	Orange	California
United States	Midwest Heart & Vasc Spec	Overland Park	Kansas
United States	Midwest Heart & Vasc Spec	Overland Park	Kansas
United States	MD Medical Research	Oxon Hill	Maryland
United States	Stanford Univ School of Med	Palo Alto	California
United States	Methodist Medical_Center of Illinois	Peoria	Illinois
United States	OSF HealthCare_Cardiovasc Inst	Peoria	Illinois
United States	Thomas Jefferson University_Philadelphia	Philadelphia	Pennsylvania
United States	Banner University Medical Ctr	Phoenix	Arizona
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	UNC Rex Healthcare	Raleigh	North Carolina
United States	Monument Health Clinical Rsrch	Rapid City	South Dakota
United States	Reid Physician Associates	Richmond	Indiana
United States	Virginia Commonwealth University	Richmond	Virginia
United States	The Valley Hosptial	Ridgewood	New Jersey
United States	The Valley Hosptial	Ridgewood	New Jersey
United States	Roanoke Heart Institute	Roanoke	Virginia
United States	Laurelton Heart Specialist PC	Rosedale	New York
United States	Laurelton Heart Specialist PC	Rosedale	New York
United States	St Johns Ctr Clin Rsch-St. Aug	Saint Augustine	Florida
United States	St Louis Heart & Vascular, P.C.	Saint Louis	Missouri
United States	VA Medical Center_Salem	Salem	Virginia
United States	Audie L. Murphy VA Hospital	San Antonio	Texas
United States	Clinical Advancement Ctr, PLLC	San Antonio	Texas
United States	San Diego Cardiac Center	San Diego	California
United States	North America Research Institute	San Dimas	California
United States	Saratoga Clinical Research	Saratoga Springs	New York
United States	Swedish Medical Center_Seattle	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Sherman Clinical Research	Sherman	Texas
United States	Sanford Health_Sioux Falls	Sioux Falls	South Dakota
United States	Providence Med Research Ctr	Spokane	Washington
United States	Cardiology Associates of Fairfield County	Stamford	Connecticut
United States	Manshadi Heart Institute	Stockton	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	Lundquist Inst-Biomed Innovtn	Torrance	California
United States	Cardiolg Assoc Rsch LLC_Tupelo	Tupelo	Mississippi
United States	InvivoCure	Van Nuys	California
United States	Cardio Partners Clin Res Inst	Wellington	Florida
United States	Selma Medical Associates	Winchester	Virginia
United States	Valley Health Link	Winchester	Virginia
United States	Winter Haven Hospital	Winter Haven	Florida
United States	Penn State Health-Berks Cardiology	Wyomissing	Pennsylvania
United States	Trinity Health Michigan Heart	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  China,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  North Macedonia,  Norway,  Poland,  Portugal,  Romania,  Serbia,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Time to First Occurrence of 4-point Expanded Composite HF Endpoint, a Composite Endpoint Consisting of: CV Death, HF Hospitalisation or Urgent HF Visit, Non-fatal Myocardial Infarction (MI), Non-fatal Stroke	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Number of CV Deaths, HF Hospitalisations or Urgent HF Visits (First and Recurrent)	Measured as count of event.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Time to Occurrence of CV Death	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Time to Occurrence of all-cause Death	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Time to First Occurrence of 4-point Expanded Composite HF Endpoint, a Composite Endpoint Consisting of: All-cause Death, HF Hospitalisation or Urgent HF Visit, Non-fatal MI, Non-fatal stroke	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Hierarchical Composite of: Time to All-cause Death, Number of HF Hospitalisations or Urgent HF Visits, Time to First HF Hospitalisation or Urgent HF Visit, difference of at least 5 in KCCQ clinical summary score change from baseline to 12 months	Kansas City Cardiomyopathy Questionnaire (KCCQ) measures Health-Related Quality of Life (HRQOL) and is a disease-specific health status instrument for HF. Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms, and greater disease-specific health related quality of life, respectively. Measured as total wins for each treatment group.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Time to First Occurrence of HF Hospitalisation or Urgent HF Visit	Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Number of Events of Atrial Fibrillation	Measured as count of event.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Change in KCCQ Clinical Summary Score	KCCQ measures Health-Related Quality of Life (HRQOL) and is a disease-specific health status instrument for HF. Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms, and greater disease-specific health related quality of life, respectively. Measured as score.	From randomisation (month 0) to 12 months
Secondary	Improvement of 5 Points or More in KCCQ Clinical Summary Score (Yes/No)	Kansas City Cardiomyopathy Questionnaire (KCCQ) measures Health-Related Quality of Life (HRQOL) and is a disease-specific health status instrument for HF. Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms, and greater disease-specific health related quality of life, respectively. Measured as count of participant.	From randomisation (month 0) to 12 months
Secondary	Improvement of 10 Points or More in KCCQ Clinical Summary Score (Yes/No)	Kansas City Cardiomyopathy Questionnaire (KCCQ) measures Health-Related Quality of Life (HRQOL) and is a disease-specific health status instrument for HF. Score ranges from 0 to 100, with 0 as the lowest score and 100 as the highest score. Higher scores indicate better health status, fewer symptoms, and greater disease-specific health related quality of life, respectively. Measured as count of participant.	From randomisation (month 0) to 12 months
Secondary	Improvement in New York Heart Association (Classification) [NYHA Class] (Yes/No)	NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I: Participant with cardiac disease but without resulting limitations of physical activity.; Class II: Participants with cardiac disease resulting in slight limitation of physical activity.; Class III: Participants with cardiac disease resulting in marked limitation of physical activity.; Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort.; Measured as count of participant.	From randomisation (month 0) to 12 months
Secondary	Time to First Occurrence of a Composite Chronic Kidney Disease (CKD) Endpoint Consisting of: CV death, Onset of Persistent Greater Than Equal To 40 Percentage Reduction in eGFR (CKD- EPI) compared with baseline; Kidney failure	eGFR = estimated glomerular filtration rate; CKD-EPI = chronic kidney disease - epidemiology collaboration. Kidney failure defined as: death from kidney failure, onset of persistent eGFR less than 15 milliliters per minute (mL/min)/1.73 meter square (m^2) (CKD-EPI), initiation of chronic kidney replacement therapy (maintenance dialysis or kidney transplantation). Measured in months.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Change in Estimated Glomerular Filtration Rate (eGFR) (Chronic Kidney Disease - Epidemiology Collaboration [CKD-EPI])	Measured as mL/min/1.73 m^2.	From randomisation (month 0) to 12 months
Secondary	Annual Rate of Change in eGFR (CKD-EPI) (Total eGFR Slope)	Measured as mL/min/1.73 m^2/year.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Number of Hospitalisations With Infection as Primary Cause or Death Due to Infection	Measured as count of event.	From randomisation (month 0) to end of study (up to 48 months)
Secondary	Change in High-sensitivity C-reactive Protein (hs-CRP)	Measured as ratio to baseline.	From randomisation (month 0) to 12 months
Secondary	Change in N-terminal-pro-brain Natriuretic Peptide (NT-proBNP)	Measured as ratio to baseline.	From randomisation (month 0) to 12 months