Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure

Chronic Heart Failure Clinical Trial

— ATMOSPHERE  

Official title:

A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853658
• Other study ID #: CSPP100F2301
• Secondary ID: 2008-004104-31
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2009
• Last updated: April 7, 2016
• Start date: March 2009
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: National Health and Medical Research CouncilAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: Ministry of HealthCanada: Health CanadaChina: Food and Drug AdministrationColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCosta Rica: Ethics CommitteeEstonia: The State Agency of MedicineCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyIceland: Icelandic Medicines Control AgencyIndia: Central Drugs Standard Control OrganizationIreland: Medical Ethics Research CommitteeItaly: National Institute of HealthJapan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Norway: Norwegian Medicines AgencyPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencyRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: SwissmedicTaiwan: Department of HealthThailand: Ministry of Public HealthTurkey: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyVenezuela: Ministry of Health and Social Development
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7126
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a diagnosis of chronic heart failure (NYHA Class II - IV):

• LVEF = 35% at visit 1. (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography)

• Elevated BNP at visit 1: BNP = 150 pg/ml (according to local measurement).

• BNP = 100 pg/ml (according to local measurement) and unplanned hospitalization with HF within the last 12 months prior visit 1.

• Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg daily at least or any other ACE inhibitor, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses as described in the dose equivalence guidance table of ACEi's) for at least 4 weeks prior to visit 1

Exclusion Criteria:

• History of hypersensitivity to any of the study drugs including history or allergy to ACEi's as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEi's during up titration process.

• Patients treated concomitantly with both ARB and aldosterone antagonist in addition to study drug at visit 1.

• Current acute decompensated HF.

• Symptomatic hypotension and/or less than 95 mmHg SBP at visit 1 and/or less than 90 mmHg at visit 4.

• Renal disease likely to be life threatening or eGFR < 40 ml/min/1.73m2 as measured by the MDRD formula at visit 1 and eGFR < 35 ml/min/1.73m2 as measured by the MDRD formula at visit 4 or decrease of eGFR of more than 25% from visit 1 to visit 4 (according to local laboratory measurement).

• Serum potassium = 5.0 mmol/L at visit 1 or = 5.2 mmol/L at visit 4 (according to local laboratory measurement).

• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to visit 1.

• Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after visit 1.

• Right heart failure due to severe pulmonary disease

• Patients with diabetes mellitus

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Enalapril monotherapy
Enalapril monotherapy -10 mg
• Aliskiren monotherapy
Aliskiren monotherapy-150 mg titrated to 300 mg
• Aliskiren / Enalapril combination therapy
Aliskiren / Enalapril combination therapy- 150 mg/10 mg titrated to 300 mg/ 10 mg

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Bahia Blanca	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Caba	Buenos Aires
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Cordoba
Argentina	Novartis Investigative Site	Córdoba	Cordoba
Argentina	Novartis Investigative Site	Coronel Suarez	Buenos Aires
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	La Plata	Buenos Aires
Argentina	Novartis Investigative Site	Posadas	Misiones
Argentina	Novartis Investigative Site	Quilmes	Buenos Aires
Argentina	Novartis Investigative Site	Ramos Mejia	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Salta
Argentina	Novartis Investigative Site	San Isidro	Buenos Aires
Argentina	Novartis Investigative Site	San Miguel de Tucuman	Tucuman
Argentina	Novartis Investigative Site	San Nicolas	Buenos Aires
Argentina	Novartis Investigative Site	Tucuman	San Miguel de Tucuman
Argentina	Novartis Investigative Site	Va Allende	Cordoba
Argentina	Novartis Investigative Site	Villa Maria	Cordoba
Australia	Novartis Investigative Site	Auchenflower	Queensland
Australia	Novartis Investigative Site	Bedford Park	South Australia
Australia	Novartis Investigative Site	Canberra	Australian Capital Territory
Australia	Novartis Investigative Site	Darlinghurst	New South Wales
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Kingswood	New South Wales
Australia	Novartis Investigative Site	Launceston	Tasmania
Australia	Novartis Investigative Site	Prahran	Victoria
Australia	Novartis Investigative Site	Wollongong	New South Wales
Australia	Novartis Investigative Site	Woolloongabba	Queensland
Australia	Novartis Investigative Site	Wooloongabba	Queensland
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Innsbruck	Tyrol
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Belgium	Novartis Investigative Site	Anderlecht
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Brussels
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	De Pinte
Belgium	Novartis Investigative Site	Eupen
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Huy
Belgium	Novartis Investigative Site	Ieper
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Turnhout
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Brasilia	DF
Brazil	Novartis Investigative Site	Campina Grande do Sul	PR
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Caxias do Sul	RS
Brazil	Novartis Investigative Site	Curitiba	PR
Brazil	Novartis Investigative Site	Fortaleza	CE
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Londrina	PR
Brazil	Novartis Investigative Site	Marilia	SP
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Recife	PE
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China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
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China	Novartis Investigative Site	Beijing	Beijing
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Dominican Republic	Novartis Investigative Site	San Cristobal
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Estonia	Novartis Investigative Site	Tartu
Finland	Novartis Investigative Site	Hyvinkää
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France	Novartis Investigative Site	Albi
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France	Novartis Investigative Site	Marseille Cedex 05
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Vandoeuvre Les Nancy
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Bad Nauheim
Germany	Novartis Investigative Site	Bad Neustadt an der Saale
Germany	Novartis Investigative Site	Bensheim
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Brake
Germany	Novartis Investigative Site	Celle
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Coburg
Germany	Novartis Investigative Site	Darmstadt
Germany	Novartis Investigative Site	Dessau-Roßlau
Germany	Novartis Investigative Site	Dinkelsbühl
Germany	Novartis Investigative Site	Dorsten
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Duisburg
Germany	Novartis Investigative Site	Düsseldorf
Germany	Novartis Investigative Site	Ebersbach
Germany	Novartis Investigative Site	Erfurt
Germany	Novartis Investigative Site	Erkner
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Goettingen
Germany	Novartis Investigative Site	Gotha
Germany	Novartis Investigative Site	Göttingen
Germany	Novartis Investigative Site	Gütersloh
Germany	Novartis Investigative Site	Halle (Saale)
Germany	Novartis Investigative Site	Halle/'Saale
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hassloch
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Heilbronn
Germany	Novartis Investigative Site	Helmbrechts
Germany	Novartis Investigative Site	Heppenheim
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Kleve
Germany	Novartis Investigative Site	Koblenz
Germany	Novartis Investigative Site	Köln
Germany	Novartis Investigative Site	Königsbrück
Germany	Novartis Investigative Site	Köthen
Germany	Novartis Investigative Site	Krefeld
Germany	Novartis Investigative Site	Lambrecht
Germany	Novartis Investigative Site	Landshut
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Lichtentanne
Germany	Novartis Investigative Site	Lienen
Germany	Novartis Investigative Site	Lörrach
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Lüneburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Markkleeberg
Germany	Novartis Investigative Site	Mayen
Germany	Novartis Investigative Site	Melsungen
Germany	Novartis Investigative Site	Muehldorf am Inn
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muhlheim an der Ruhr
Germany	Novartis Investigative Site	Mülheim
Germany	Novartis Investigative Site	Northeim
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Oelde
Germany	Novartis Investigative Site	Oelde
Germany	Novartis Investigative Site	Pirna
Germany	Novartis Investigative Site	Potsdam
Germany	Novartis Investigative Site	Reinfeld
Germany	Novartis Investigative Site	Salzwedel
Germany	Novartis Investigative Site	Schwäbisch Hall
Germany	Novartis Investigative Site	Schwalmstadt
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Stade
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Wedel
Germany	Novartis Investigative Site	Winsen	Lower Saxony
Germany	Novartis Investigative Site	Witten
Germany	Novartis Investigative Site	Wuerzburg
Germany	Novartis Investigative Site	Zwickau
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Chios
Greece	Novartis Investigative Site	Edessa
Greece	Novartis Investigative Site	Thessaloniki	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
India	Novartis Investigative Site	Ahmedabad	Gujarat
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bangalore
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Delhi	New Delhi
India	Novartis Investigative Site	Guntur	Andhra Pradesh
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India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Hyderabad
India	Novartis Investigative Site	Hyderabad
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Jaipur	Rajasthan
India	Novartis Investigative Site	Lucknow
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India	Novartis Investigative Site	Mumbai	Maharashtra
India	Novartis Investigative Site	Mumbai
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
India	Novartis Investigative Site	Nagpur	Maharashtra
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India	Novartis Investigative Site	New Delhi
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India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Pune	Maharashtra
India	Novartis Investigative Site	Secunderabad	Andhra Pradesh
India	Novartis Investigative Site	Trivandrum	Kerela
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Ireland	Novartis Investigative Site	Co Dublin
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Ireland	Novartis Investigative Site	Dublin 7
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Italy	Novartis Investigative Site	Ancona	AN
Italy	Novartis Investigative Site	Arezzo	AR
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Casarano	LE
Italy	Novartis Investigative Site	Castelnuovo di Garfagnana	LU
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Italy	Novartis Investigative Site	Cecina	LI
Italy	Novartis Investigative Site	Chieti	CH
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Italy	Novartis Investigative Site	Cotignola	RA
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Italy	Novartis Investigative Site	Montescano	(pv)
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Japan	Novartis Investigative Site	Amagasaki-city	Hyogo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiba-city	Chiba
Japan	Novartis Investigative Site	Chikushino-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukushima
Japan	Novartis Investigative Site	Hamada	Shimane
Japan	Novartis Investigative Site	Higashiibaraki-gun	Ibaraki
Japan	Novartis Investigative Site	Hiroshima-city	Hiroshima
Japan	Novartis Investigative Site	Hitachinaka	Ibaraki
Japan	Novartis Investigative Site	Hofu	Yamaguchi
Japan	Novartis Investigative Site	Iizuka-city	Fukuoka
Japan	Novartis Investigative Site	Inba-gun	Chiba
Japan	Novartis Investigative Site	Izumisano-city	Osaka
Japan	Novartis Investigative Site	Kanazawa	Ishikawa
Japan	Novartis Investigative Site	Kashihara-city	Nara
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kita-ku	Osaka
Japan	Novartis Investigative Site	Komatsushima-city	Tokushima
Japan	Novartis Investigative Site	Kumamoto City	Kumamoto
Japan	Novartis Investigative Site	Kure	Hiroshima
Japan	Novartis Investigative Site	Kurume-city	Fukuoka
Japan	Novartis Investigative Site	Nagasaki
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Ogaki-city	Gifu
Japan	Novartis Investigative Site	Okayama-city	Okayama
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Saga
Japan	Novartis Investigative Site	Sagamihara-city	Kanagawa
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sendai-city	Miyagi
Japan	Novartis Investigative Site	Seto-city	Aichi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shunan-city	Yamaguchi
Japan	Novartis Investigative Site	Tokushima-city	Tokushima
Japan	Novartis Investigative Site	Toyama
Japan	Novartis Investigative Site	Tsukuba-city	Ibaraki
Japan	Novartis Investigative Site	Ube	Yamaguchi
Japan	Novartis Investigative Site	Ureshino	Saga
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokosuka	Kanagawa
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Daejeon
Korea, Republic of	Novartis Investigative Site	Gwangju
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Seongnam	Gyeonggi
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Taegu
Latvia	Novartis Investigative Site	Daugavpils
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Latvia	Novartis Investigative Site	Riga
Lithuania	Novartis Investigative Site	Kaunas	LTU
Lithuania	Novartis Investigative Site	Kaunas
Lithuania	Novartis Investigative Site	Klaipeda
Lithuania	Novartis Investigative Site	Vilnius
Mexico	Novartis Investigative Site	Aguascalientes
Mexico	Novartis Investigative Site	Culiacan	Sinaloa
Mexico	Novartis Investigative Site	Guadalajara	Jalisco
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Mexico	Novartis Investigative Site	Querétaro
Mexico	Novartis Investigative Site	San Luis Potosi
Mexico	Novartis Investigative Site	Zapopan	Jalisco
Netherlands	Novartis Investigative Site	Alkmaar
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Apeldoorn
Netherlands	Novartis Investigative Site	Deventer
Netherlands	Novartis Investigative Site	Dirksland
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Groningen
Netherlands	Novartis Investigative Site	Haarlem
Netherlands	Novartis Investigative Site	Heerlen
Netherlands	Novartis Investigative Site	Leeuwarden
Netherlands	Novartis Investigative Site	Leiderdorp
Netherlands	Novartis Investigative Site	Meppel
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Venlo
Netherlands	Novartis Investigative Site	Wildervank
Netherlands	Novartis Investigative Site	Zutphen
Netherlands	Novartis Investigative Site	Zwolle
Norway	Novartis Investigative Site	Oslo
Norway	Novartis Investigative Site	Tønsberg
Norway	Novartis Investigative Site	Trondheim
Peru	Novartis Investigative Site	Bellavista	Lima
Peru	Novartis Investigative Site	Cercado de Lima	Lima
Peru	Novartis Investigative Site	Chiclayo	Lambayeque
Peru	Novartis Investigative Site	Jesus Maria	Lima
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	Miraflores	Lima
Peru	Novartis Investigative Site	San Borja	Lima
Peru	Novartis Investigative Site	San Isidro	Lima
Peru	Novartis Investigative Site	San Juan de Miraflores	Lima
Peru	Novartis Investigative Site	Trujillo	La Libertad
Poland	Novartis Investigative Site	Bytom
Poland	Novartis Investigative Site	Chorzow
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gdynia
Poland	Novartis Investigative Site	Gliwice
Poland	Novartis Investigative Site	Grodzisk Mazowiecki
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Katowice
Poland	Novartis Investigative Site	Klodzko
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Lomza
Poland	Novartis Investigative Site	Olawa
Poland	Novartis Investigative Site	Opole
Poland	Novartis Investigative Site	Ostrow Wielkopolski
Poland	Novartis Investigative Site	Ostrowiec Swietokrzyski
Poland	Novartis Investigative Site	Piotrkow Trybunalski
Poland	Novartis Investigative Site	Plock
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Sandomierz
Poland	Novartis Investigative Site	Tarnow
Poland	Novartis Investigative Site	Torun
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Wroclaw
Poland	Novartis Investigative Site	Zabrze
Portugal	Novartis Investigative Site	Amadora
Portugal	Novartis Investigative Site	Aveiro
Portugal	Novartis Investigative Site	Carnaxide
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Faro
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Penafiel
Portugal	Novartis Investigative Site	Porto
Puerto Rico	Novartis Investigative Site	Humacao
Puerto Rico	Novartis Investigative Site	Ponce
Puerto Rico	Novartis Investigative Site	San Juan
Romania	Novartis Investigative Site	Baia Mare
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Brasov
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 1
Romania	Novartis Investigative Site	Bucharest	District 2
Romania	Novartis Investigative Site	Cluj Napoca
Romania	Novartis Investigative Site	Cluj-Napoca
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Romania	Novartis Investigative Site	Iasi	Jud. Iasi
Romania	Novartis Investigative Site	Oradea
Romania	Novartis Investigative Site	Pitesti
Romania	Novartis Investigative Site	Targu Mures
Romania	Novartis Investigative Site	Targu Mures	jud Mures
Romania	Novartis Investigative Site	Targu Mures	Mures
Romania	Novartis Investigative Site	Timisoara
Romania	Novartis Investigative Site	Timisoara
Russian Federation	Novartis Investigative Site	Barnaul
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Ekaterinburg
Russian Federation	Novartis Investigative Site	Izhevsk
Russian Federation	Novartis Investigative Site	Kirov
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Kursk
Russian Federation	Novartis Investigative Site	Lubertsi
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Nizhny Novgorod
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Omsk
Russian Federation	Novartis Investigative Site	Perm
Russian Federation	Novartis Investigative Site	Pushkin,St-Petersburg
Russian Federation	Novartis Investigative Site	Ryazan
Russian Federation	Novartis Investigative Site	S.-Petersburg
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saint-Petersburg
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	St-Petersburg
Russian Federation	Novartis Investigative Site	St. Petersburg
Russian Federation	Novartis Investigative Site	Tyumen
Russian Federation	Novartis Investigative Site	Volgograd
Russian Federation	Novartis Investigative Site	Volgograd
Russian Federation	Novartis Investigative Site	Voronezh
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Russian Federation	Novartis Investigative Site	Yaroslavl
Slovakia	Novartis Investigative Site	Bardejov
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava	Slovak Republic
Slovakia	Novartis Investigative Site	Komarno	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak Republic
Slovakia	Novartis Investigative Site	Kosice	Slovak republic
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Kosice
Slovakia	Novartis Investigative Site	Levice	Slovak Republic
Slovakia	Novartis Investigative Site	Lucenec
Slovakia	Novartis Investigative Site	Nitra	Slovak Republic
Slovakia	Novartis Investigative Site	Piestany
Slovakia	Novartis Investigative Site	Povazska Bystrica	Slovak republic
Slovakia	Novartis Investigative Site	Presov	Slovak republic
Slovakia	Novartis Investigative Site	Presov
Slovakia	Novartis Investigative Site	Stropkov	Slovak republic
Slovakia	Novartis Investigative Site	Trebisov
Slovakia	Novartis Investigative Site	Trencin
Slovakia	Novartis Investigative Site	Zilina
Slovakia	Novartis Investigative Site	Zilina	Slovak Republic
Slovakia	Novartis Investigative Site	Zilina	Slovak Republic
South Africa	Novartis Investigative Site	Benoni
South Africa	Novartis Investigative Site	Boksburg
South Africa	Novartis Investigative Site	Cape Town
South Africa	Novartis Investigative Site	Centurion
South Africa	Novartis Investigative Site	Johannesburg
South Africa	Novartis Investigative Site	Soweto	Gauteng
South Africa	Novartis Investigative Site	Worcester
Spain	Novartis Investigative Site	Alicante	Comunidad Valenciana
Spain	Novartis Investigative Site	Badalona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Barcelona
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Sanlucar de Barrameda	Andalucia
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Tarragona	Catalunya
Spain	Novartis Investigative Site	Tortosa	Cataluña
Spain	Novartis Investigative Site	Utrera	Andalucia
Spain	Novartis Investigative Site	Valdemoro	Madrid
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Villamartin	Cadiz
Sweden	Novartis Investigative Site	Falun
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Karlstad
Sweden	Novartis Investigative Site	Linkoping
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Malmo
Sweden	Novartis Investigative Site	Malmö
Sweden	Novartis Investigative Site	Malmö
Sweden	Novartis Investigative Site	Mölndal
Sweden	Novartis Investigative Site	Nässjö
Sweden	Novartis Investigative Site	Örebro
Sweden	Novartis Investigative Site	Skelleftea
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Sundsvall
Sweden	Novartis Investigative Site	Sundsvall
Sweden	Novartis Investigative Site	Umeå
Sweden	Novartis Investigative Site	Uppsala
Sweden	Novartis Investigative Site	Västerås
Switzerland	Novartis Investigative Site	Basel
Switzerland	Novartis Investigative Site	Bellinzona
Switzerland	Novartis Investigative Site	Bern
Switzerland	Novartis Investigative Site	Biel
Switzerland	Novartis Investigative Site	Bruderholz
Switzerland	Novartis Investigative Site	Lugano
Switzerland	Novartis Investigative Site	Olten
Switzerland	Novartis Investigative Site	Winterthur
Switzerland	Novartis Investigative Site	Zuerich
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Tainan 704	Taiwan ROC
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Yungkang	Tainan
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Aydin
Turkey	Novartis Investigative Site	Balcova
Turkey	Novartis Investigative Site	Etlik / Ankara
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
Turkey	Novartis Investigative Site	Kinikli / Denizli
Turkey	Novartis Investigative Site	Kocaeli
Turkey	Novartis Investigative Site	Sivas
United Kingdom	Novartis Investigative Site	Addlestone	Surrey
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Chesterfield
United Kingdom	Novartis Investigative Site	Chichester	West Sussex
United Kingdom	Novartis Investigative Site	Colchester
United Kingdom	Novartis Investigative Site	Dafen	Llanelli
United Kingdom	Novartis Investigative Site	East Yorkshire
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Leicester	Leicestershire
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Southampton
United Kingdom	Novartis Investigative Site	Swindon
United Kingdom	Novartis Investigative Site	Worthing	West Sussex
United States	Novartis Investigative Site	Athens	Georgia
United States	Novartis Investigative Site	Auburn	Maine
United States	Novartis Investigative Site	Augusta	Georgia
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Boynton Beach	Florida
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Daytona Beach	Florida
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Elmer	New Jersey
United States	Novartis Investigative Site	Everett	Washington
United States	Novartis Investigative Site	Fort Lauderdale	Florida
United States	Novartis Investigative Site	French Camp	California
United States	Novartis Investigative Site	Germantown	Tennessee
United States	Novartis Investigative Site	Gillespie	Illinois
United States	Novartis Investigative Site	Hollywood	Florida
United States	Novartis Investigative Site	Hot Springs	Arkansas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Huntsville	Alabama
United States	Novartis Investigative Site	Inglewood	California
United States	Novartis Investigative Site	Jacksonville Beach	Florida
United States	Novartis Investigative Site	Kirkland	Washington
United States	Novartis Investigative Site	Laurelton	New York
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Little Rock	Arkansas
United States	Novartis Investigative Site	Littleton	Colorado
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Metairie	Louisiana
United States	Novartis Investigative Site	Miami Lakes	Florida
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Modesto	California
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Orleans	Louisiana
United States	Novartis Investigative Site	Northridge	California
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orlando	Florida
United States	Novartis Investigative Site	Pine Bluff	Arkansas
United States	Novartis Investigative Site	Sacramento	California
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	Searcy	Arkansas
United States	Novartis Investigative Site	Slidell	Louisiana
United States	Novartis Investigative Site	Southfield	Michigan
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Stony Brook	New York
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Varnville	South Carolina
United States	Novartis Investigative Site	Wellington	Florida
United States	Novartis Investigative Site	Westlake Village	California
United States	Novartis Investigative Site	Wiliamsville	New York
Venezuela	Novartis Investigative Site	Barcelona	Estado Anzoátegui
Venezuela	Novartis Investigative Site	Caracas	Distrito Capital
Venezuela	Novartis Investigative Site	Caracas	Distrito Capital
Venezuela	Novartis Investigative Site	Caracas	Distrito Capital
Venezuela	Novartis Investigative Site	Caracas	Estado Miranda
Venezuela	Novartis Investigative Site	Cumana	Estado Sucre
Venezuela	Novartis Investigative Site	Maracaibo	Estado Zulia
Venezuela	Novartis Investigative Site	Puerto Ordaz	Estado Bolívar
Venezuela	Novartis Investigative Site	Valencia	Edo. Carabobo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Colombia,  Costa Rica,  Czech Republic,  Denmark,  Dominican Republic,  Estonia,  Finland,  France,  Germany,  Greece,  India,  Ireland,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delaying time to first occurrence of either cardiovascular death or heart failure hospitalization in patients with chronic heart failure		4 years	No
Secondary	Improvement in the clinical summary score (assessed by KCCQ) from baseline to predefined timepoint.		1 year	No