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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05350202
Other study ID # 1245-0259
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 15, 2022
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multinational non-interventional study based on newly collected data to assess demographics, disease, and treatment pattern of patients with chronic Heart Failure (HF) in a two-cohort design: one cohort will receive first prescription of empagliflozin as routine therapy for HF, the other cohort will receive HF therapy with drugs with another mechanism of action. Treatment of HF according to routine practice is determined by the physician independent of the participation of the patient in this non-interventional study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3451
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Written informed consent prior to study participation - Male and female patients = 18 years at Visit 1 - Patients must be contractually capable and mentally able to understand and follow the instructions of the study personnel - Patients with diagnosis of chronic heart failure NYHA Class 2-4 - Treatment-naïve for SGLT2i at visit 1 - Women of childbearing potential must take appropriate precautions against getting pregnant according to approval of chosen HF drug(s) Exclusion Criteria: - Missing physician's diagnosis of chronic heart failure - Patients hospitalized at visit 1 - Life expectancy = 12 months according to physician's assessment - Lack of informed consent - Pregnant or lactating females - Participation in a parallel interventional clinical trial - Chosen treatment with another SGLT2i drug than empagliflozin - Having been enrolled into the non-empagliflozin-arm of this non-interventional study - Current or prior treatment with SGLT2i at visit 1 - Patients with contraindications according to current Summary of Product Characteristics (SmPC) - Patients with dependency or relationship to the treating physician

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Empagliflozin
Empagliflozin

Locations

Country Name City State
Bulgaria Dr. Mircheva Burgas
Bulgaria Dr. Yordanov Haskovo
Bulgaria MBAL Atanas Dafovski, Kardzhali Kardjali
Bulgaria Dr. Krasteva Kyustendil
Bulgaria Dr. Todorov Lovech
Bulgaria Dr. Tsoneva Lovech
Bulgaria Dr. Pavlov Parvomay
Bulgaria Medical Center, Pazardjik Pazardzhik
Bulgaria Dr. Stankova Pernik
Bulgaria assoc.prof. Gospodinov Pleven
Bulgaria dr. Kostadinovska Pleven
Bulgaria prof.Tisheva Pleven
Bulgaria Dr. Filipov Plovdiv
Bulgaria Dr. Hairabedian Plovdiv
Bulgaria Dr. Ilchev Plovdiv
Bulgaria Dr. Mekenian Plovdiv
Bulgaria MBAL Sliven, Dr. Bletsova Sliven
Bulgaria dr. Garvanski Sofia
Bulgaria dr. Georgieva Sofia
Bulgaria dr. Karchinova Sofia
Bulgaria Dr. Naidenova Sofia
Bulgaria Dr. Nossikov Sofia
Bulgaria Dr. Pancheva Sofia
Bulgaria dr. Petrusheva Sofia
Bulgaria Dr. Varnaliiska Sofia
Bulgaria prof. Karamfiloff Sofia
Bulgaria prof. Velchev Sofia
Bulgaria prof.Vitlianova Sofia
Bulgaria Dr. Gospodinov Stara Zagora
Bulgaria Dr. Trendafilova Targovishte
Bulgaria dr. Belcheva Varna
Bulgaria dr. Gyuzelev Varna
Bulgaria dr. Mancheva Varna
Bulgaria Dr. Petrova Yambol
Bulgaria Dr. Toneva-Zhelaeva Yambol
Czechia KARDIO GRÉZL, s.r.o. Šumperk
Czechia MUDr. Hana Burianová Bílovec
Czechia Fakultní nemocnice u sv. Anny v Brne Brno
Czechia MUDr. Karel Kameník s.r.o. Brno
Czechia MUDr. Libor Nechvátal s.r.o. Brno
Czechia Zdravá srdce s.r.o. Brno
Czechia Kardiologická ambulance Brno, s.r.o. Brno - Královo Pole
Czechia EDUMED s.r.o. Broumov
Czechia EDUMED s.r.o. - Dr. Švarcová Broumov
Czechia EDUMED s.r.o. - Dr. Nováková Broumov
Czechia EDUMED s.r.o. - Dr. Polášková Broumov
Czechia Kardiologická ambulance Ceský krumlov Ceský Krumlov
Czechia CorMedico s.r.o. Frýdek-Místek
Czechia DIKa centrum s.r.o. Havírov
Czechia Lékarský servis, a.s. Havírov
Czechia Kardio Pudich s.r.o. Hlucín
Czechia ProKardio HK, s.r.o. Hradec králové
Czechia Nemocnice Jihlava - Kardiologické oddelení Jihlava
Czechia Oblastní nemocnice Kolín, a.s. nemocnice Stredoceského kraje Kolín
Czechia KardioBušák s.r.o. Louny
Czechia Kardiomost s.r.o. Most
Czechia Nemocnice AGEL Nový Jicín, a.s. Nový Jicín
Czechia Kardiologická ambulance Olomouc Olomouc
Czechia Kardiologická ambulance Mammed Ostrava
Czechia Nemocnice AGEL Ostrava-Vítkovice a.s. - Kardiologická ambulance Ostrava
Czechia OVAKARD s.r.o. Ostrava
Czechia Poliklinika Nová Hut Ostrava
Czechia Fakultní nemocnice Ostrava Ostrava - Poruba
Czechia Kardiologie Vinohrady s.r.o. Prague
Czechia Kardiologie prof. Táborský s.r.o. Praha 2
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia MEDICON a.s. Praha 4
Czechia Clinical Trials Service s.r.o. Praha 5
Czechia Nemocnice na Homolce Praha 5
Czechia ROcardia s.r.o. Prostejov
Czechia Galenica Medical s.r.o. Prostrední Suchá
Czechia Všeobecná interní ambulance s.r.o. Tábor
Czechia Nemocnice AGEL Trinec-Podlesí a.s. Trinec Podlesí
Czechia Kardiologická ambulance MUDr. Ferkl s.r.o. Trutnov
Czechia Lunacor s.r.o. Vizovice
Czechia Krajská nemocnice T. Bati, a.s. Zlín
Hungary Állami Szívkórház Balatonfüred
Hungary Gottsegen György National Cardiovascular Center Budapest
Hungary Heart and Vascular Centre, Semmelweis University Budapest
Hungary Sante Cons Bt. Budapest
Hungary DE Klinikai Központ Kardiológia és Szívsebészet Debrecen
Hungary Dombóvári Szent Lukács Kórház Dombóvár
Hungary Lahynara Bt Dunavarsany
Hungary Kardiológia Magánrendelo Eger
Hungary Mohácsi Kórház Mohács
Hungary Coromed-Smo Pécs
Hungary University of Pécs Pécs
Hungary Soproni Erzsébet Oktató Kórház Sopron
Hungary Újszeged Egészségközpont Szeged
Poland ECHOKardio Poradnia Kardiologiczna Bialystok
Poland Kardiologiczna Praktyka Lekarska Anna Tomaszuk-Kazberuk Bialystok
Poland Klinika Kardiologii Uniwersyteckiego Szpitala Klinicznego w Bialymstoku Bialystok
Poland Podlaski Osrodek Kardiologii Bialystok
Poland Specjalistyczna Praktyka Lekarska Marek Styczkiewicz Brzozów
Poland BlueMed - Centrum Medyczne Bydgoszcz
Poland Centrum Kardiologii Pawel Grzelakowski Bydgoszcz
Poland Centrum Medyczne A i D Nowak sj Bydgoszcz
Poland Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Lugowski Bydgoszcz
Poland Specjalistyczna Praktyka Lekarska Grzegorz Grzesk Bydgoszcz
Poland Indywidualna Specjalistyczna Praktyka Lekarska Jolanta Nowak Bytom
Poland Specjalistyczna Praktyka Lekarska Agata Fenger Chorozow
Poland Med. - Zone sp zoo Cieszyn
Poland Specjalistyczna Praktyka Lekarska lek.n.med.Lucyna Góras-Hetmanczyk Czeladz
Poland Gabinet Kardiologiczny - Jacek Jafra Czestochowa
Poland Prywatna Praktyka Lekarska Artur Dekiela Czestochowa
Poland Specjalistyczna Praktyka Lekarska Magdalena Miczko Dabrowa Górnicza
Poland ISPL Malgorzata Dobrowolska Gabinet Tendo Gdynia
Poland Specjalistyczna Praktyka Lekarska Wojciech Czapla Gliwice
Poland Miedziowe Centrum Zdrowia S.A. Glogów
Poland Centrum Medyczne NIWA Glogów Malopolski
Poland Indywidualna Praktyka Lekarska Tomasz Zielinski Grodzisk Mazowiecki
Poland Przychodnia Lekarska Zdrowy Mis Grójec
Poland Indywidualna Praktyka Lekarska Piotr Tokarczyk Inowroclaw
Poland Familia Medicina Sp. z o.o. Iwanowice Wloscianskie
Poland Specjalistyczna Praktyka Lekarska Jaroslaw Pazdzierz Jaslo
Poland Specjalistyczna Praktyka Lekarska Urszula Winiarska-Walus Jastrzebie Zdrój
Poland Dorota Adamczyk-Kot NZOZ-KARDIO Jedrzejów
Poland Centrum Medyczne Kinesis Kamien
Poland Praktyka Lekarska Wojciech Kwasniewski Katowice
Poland Prywatna Przychodnia Specjalistyczna Drozd Zbigniew Gasior Katowice
Poland CUM PromontMed Kielce
Poland Arsmedica Specjalistyczna Praktyka Lekarska lek.med. Krzysztof Czerniejewski Konin
Poland Prywatny Gabinet Kardiologiczny lek. med. Slawomir Kepski Konin
Poland Specjalistyczna Praktyka Lekarska Pawel Michalski Konin
Poland Poliklinika MSWiA/Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Jarzabek Koszalin
Poland Uromed Sp Zoo Koszalin
Poland Indywidualna Praktyka Lekarska Krzysztof Maslak Kozminek
Poland Centrum Medyczne Dietla 19 sp. Z o.o. Kraków
Poland Centrum Twojego Zdrowia Kraków
Poland CM Oficerskie Kraków
Poland Poradnia Kardiologiczna, Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Kraków
Poland Specjalistyczna Praktyka Lekarska "Kardiolek" Dr med. Piotr Wilkolek Kraków
Poland Prywatny Gabinet Kardiologiczny Dr n.med Janusz Bak Kranse
Poland Centrum Medyczne Debina Kroscienko Wyzne
Poland Poradnia Kardiologiczna Centrum Medyczne w Lancucie Lancut
Poland SP ZOZ Leczna Leczna
Poland Beata Miklaszewicz&Dariusz Dabrowski Cardiamed S.J. Legnica
Poland NZOZ DUOMED S.C. Poradnia Kardiologiczna Legnica
Poland Prywatny Specjalistyczny Gabinet Kardiologiczno-Internistyczny Libiaz
Poland Nzoz Salusmed Lódz
Poland Santa Sp. z o.o. Lódz
Poland Indywidualna Specjalistyczna Praktyka Lekarska - Renata Leniec Lublin
Poland Kardiologiczna Praktyka Lekarska Wojciech Kula Lublin
Poland NZOZ Sanus Jacek Madej Lublin
Poland NZOZ Sanus Jacek Madej Poradnia kardiologiczna Lublin
Poland Provivo Specjalistyczne Centrum Medyczne Lublin
Poland Kardiologiczno - Internistyczny Gabinet Lekarski Skrzynski Andrzej Luków
Poland Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczne Gabinety lekarskie Mikolów
Poland Gabinet Lekarski Kardiologiczny Mirków
Poland Prywatne Uslugi Medyczne Jacek Morka Modliszewice
Poland Indywidualna Specjalistyczna PraktyKa Lekarska-Piotr Utz Moszczenica
Poland Gabinet Lekarski Ewa Burchard Nowe Miasto nad Pilica
Poland Medyczne Centrum Zdrovita Nowy Tomysl
Poland Olesnica Prywatna Praktyka Lekarska Olesnica
Poland SZOZ Jantar Sp. z o.o. Poradnia Lekarzy Specjalistów Ostrów Wielkopolski
Poland GVM CARINT Oswiecim Oswiecim
Poland Specjalistyczna Praktyka Lekarska Rafal Nowak Piasek
Poland Specjalistyczna Praktyka Lekarska Andrzej Beben Piotrków Trybunalski
Poland Indywidualna Specjalistyczna Praktyka Lekarska Maciej Strawczynski Plock
Poland Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Bolewski Poznan
Poland Wojewódzki Szpital im. sw. Ojca Pio w Przemyslu Przemysl
Poland Leszek Kaminski Specjalistyczny Gabinet Lekarski Przeworsk
Poland Praktyka Lekarska Katarzyna Czarnecka Pszczyna
Poland PCK - Pulawskie Centrum Kardiologiczne Przychodnia Specjalistyczna Pulawy
Poland Poradnia Kardiologiczna SPZOZ Pulawy Pulawy
Poland Indywidualna Specjalistyczna Praktyka Lekarska Magdalena Poterala Radom
Poland Poradnia Kardioogiczna Zegara Slonecznego Radom
Poland Specjalistyczna Praktyka Lekarska Radzionków Radzionków
Poland Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Alicja Galuszka-Bilinska Rybnik
Poland Specjalistyczna Praktyka Lekarska Wieslawa Faberska-Blicharska Rybnik
Poland Centrum Medyczne Sabamed Rzeszów
Poland Prywatny Gabinet Kardiologiczny dr n.med Janusz Romanek Rzeszów
Poland My Life Centrum chorób serca Sanok
Poland Specjalistyczna Praktyka Lekarska Kamila Stembalska Scinawa
Poland Monika Kujawiak Prywatna Praktyka Lekarska Siedlce
Poland Prywatny Gabinet Lekarski Hanna Wilk-Manowiec Siedlce
Poland Indywidualna praktyka lekarska Artur Marcinkiewicz Siemianowice Slaskie
Poland Asnyka 78d Gabinety Lekarskie Skierniewice
Poland Specjalistyczna Praktyka Lekarska Maciej Kazmierski Sosnowiec
Poland Specjalistyczna Praktyka Lekarska Marek Kondys Sosnowiec
Poland Powiatowy Szpital Specjalistyczny w Stalowej Woli Stalowa Wola
Poland Lekarze na Dworskiej Swiebodzin
Poland Centrum Medyczne VITA Szczecin
Poland ISPL Anna Bis Szczecin
Poland Specjalistyczna Praktyka Lekarska Tomasz Urbanik Szczecin
Poland Szpital w Szczecinku Szczecinek
Poland Gabinet Lekarski Weronika Greberska Szczytniki
Poland Specjalistyczna Praktyka Lekarska Pawel Kocik Tarnów
Poland Leomed Centrum Medyczne Tarnowskie Góry
Poland Prywatna Praktyka Lekarska na wezwanie Miroslaw Marciniak Torun
Poland Indywidualna Specjalistyczna Praktyka Lekarska - Witold Orszulak Tychy
Poland Urszula Urbanowicz Specjalistyczna Praktyka Lekarska Tychy
Poland Centrum Medyczne Nowe Miasto Walbrzych
Poland Klinika 37 Centrum Kardiologii Plowiecka Warszawa
Poland Prywatny Gabinet Lekarski Bozena Norwa-Otto Warszawa
Poland SERCE S.C. Przychodnia Lekarzy Specjalistów Warszawa
Poland Gabinet Lekarski lek med. Robert Wlodarczyk Wawrzenczyce
Poland Specjalistyczny Gabinet Lekarski Lukasz Graczykowski Wloclawek
Poland Gabinet Prywatnej Praktyki Lekarskiej Kard.-Int . Dr n.med. Brygida Przywara-Chowaniec Zabrze
Poland Specjalistyczna Prajtyka Lekarska Grazyna Glanowska Zabrze
Poland Ns Zoz Kardiologia Sp. Z.O.O. Zamosc
Poland Gabinety Lekarskie JM Kulczyccy Zary
Poland ALDEMED Centrum Medyczne Zielona Góra
Poland Prywatna Praktyka Lekarska Anna Chudoba Zyrardów
Romania Miclea Ioana - Mariana MEDIC SPECIALIST CARDIOLOG Alba-Iulia
Romania Dr. Morar Mihnea-Dragoscabinet Medical Individual - Specialist Cardiologie Arad
Romania Dr. Pop-Moldovan Adina-Ligia - Medicina Interna - Cardiologie Arad
Romania Cardio Animus SRL Bacau
Romania CMI Iosipescu Laura Cristina Bacau
Romania CMI - Centrul medical Diacord Baia Mare
Romania Mercea Corina-Delia - Medic Baia Mare
Romania Ambrinomed SRL Botosani
Romania Cardioland SRL Brasov
Romania Rus V. Horatiu - Cabinet Medical Individual de Cardiologie Brasov
Romania Cardiocare Center SRL Bucuresti
Romania Cmi Dr Georgescu Dragos Bucuresti
Romania CMI Dr. Parsa Motlagh Babak Bucuresti
Romania Cordmedica SRL Bucuresti
Romania Dr. Bogdan Stefan Nicolae Bucuresti
Romania Dr. Danet Ruxandra - Medic Cardiologie Bucuresti
Romania Dr. Geavlete Dana-Oliviana - Activitate Medicala Bucuresti
Romania Dr. Lungeanu-Juravle Laura-Activitate Medicala Bucuresti
Romania Dr. Serban Irina-Ruxandra - MEDIC PRIMAR CARDIOLOGIE Bucuresti
Romania Dumitrescu Silviu-Ionel Persoana Fizica Autorizata Bucuresti
Romania Magister Research SRL Bucuresti
Romania Medi Pro Consult SRL Bucuresti
Romania Mihaila I. Sorina - Medic Pfi Bucuresti
Romania Mihalcea Janina-Diana Medic Specialist Cardiologie Bucuresti
Romania Patrascu R. Natalia - Medic Specialist Medicina Interna Bucuresti
Romania PFA Balahura Cristian Bucuresti
Romania Popescu I. Ileana Nicoleta Medic specialist cardiologie Bucuresti
Romania S.C. Cardiomedical Team Pro S.R.L. Bucuresti
Romania S.C. Ilro Medical S.R.L Bucuresti
Romania Urocard Plus Srl Bucuresti
Romania Cardio Clinique NCS SRL Buzau
Romania Medcon SRL Buzau
Romania Medicard SRL Buzau
Romania Angioplast Medical srl Ciurea
Romania Cabinet Cardiohealt Srl Cluj Napoca
Romania Cardiotreat SRL Cluj Napoca
Romania CMI Diaconescu Iulia Dana Cluj Napoca
Romania Mediprax Centrum Cluj Napoca Cluj Napoca
Romania PFA Comsa M.Dan-Horatiu Cluj Napoca
Romania SC Adisan SRL Cluj Napoca
Romania SC Cardioprotect MED SRL Cluj Napoca
Romania SC Clujana Medica Srl Cluj Napoca
Romania Sc Dentcor Srl Cluj Napoca
Romania Sc Medicardio Andreea Srl Cluj Napoca
Romania Cardio World Health Com Mosoaia
Romania Asclepios Medicalhealth SRL Constanta
Romania Cardio Manea Adelina SRL Constanta
Romania CMI Dr Ilie Ivona Valeria Constanta
Romania Dr. Maxim George Razvan - Activitate Medicala Constanta
Romania Endodiahealth Srl Constanta
Romania Cabinet Medical Individual - Dr. Popescu Monica Craiova
Romania Hortopan Med SRL Craiova
Romania Neurocord Medical Srl Craiova
Romania SC A&C Medical Prime SRL Craiova
Romania Sc Daxiela Impex Srl Craiova
Romania Vesalius Medical S.R.L Craiova
Romania S & R Cardiobalance Srl Curtea de Arges
Romania Cardiolife Deva
Romania CMI Dr. Chiscaneanu Teodor Galati
Romania SC Maycor SRL Galati
Romania Cardiomedplus SRL Gheorghieni
Romania Medical Cardio Anghel SRL Iasi
Romania Niculescu G. Ana Irina - Medic colaborator Iasi
Romania Procardia Serv-Med 2009 SRL srl Iasi
Romania Sc Cardiocare Clinic Srl Iasi
Romania SC Cardiomed SRL Iasi Iasi
Romania Sc Cardiortomed Srl Iasi
Romania Cardioszakacs Srl, Cui 34404518 Miercurea Ciuc
Romania Polimed Center SRL, CUI 26072639 Odorheiu Secuiesc
Romania CMI Cardiomed SRL Oradea
Romania CMI Dr. Rotariu Dragos Oradea
Romania CMI Societatea civila Magheru&Magheru Oradea
Romania Dradiand SRL Oradea
Romania PFA Dr. Ardelean Adriana Ioana Oradea
Romania Sc Adriacard Srl Oradea
Romania Simed Concept SRL Ostratu
Romania Andries I. Elena - Medic Primar Cardiologie Si Medic Specialist Mi Piatra Neamt
Romania Cardiomed Alexandrescu Srl-D Piatra Neamt
Romania Dr. Corcoz Cardiologie SRL Piatra Neamt
Romania Clinica Cardiologie Dr Stanciu Viorel Pitesti
Romania Davisof San Srl Pitesti
Romania Sc Procordia Concept Srl Pitesti
Romania Cavi Clinique SRL Ploiesti
Romania SC Cardiologie Dr. Cristina Radoi SRL Ramnicu Valcea
Romania Sc Incarmed Srl Ramnicu Valcea
Romania Sc Lidermed Plus Srl Ramnicu Valcea
Romania Gx.Hatconsulting Srl Sacele
Romania Munteanu Alice-Elena - Medic Cardiolog Sat Rosu, Comuna Chiajna
Romania Voineag Olivia Medic Colaborator Scheia
Romania Batar D. Sergiu Constantin Selimbar
Romania SC Endocordis SRL Sfintu Gheorghe
Romania Cardio Stim Center SRL Sinpetru
Romania Rusu N. Ramona Iulia Medic Primar Cardiologie Suceava
Romania Diaconu Diana - Medic Cif 31885867 Tifgu Mures
Romania Cardio - DRS S.R.L Timisoara
Romania Cardio Suport SRL Timisoara
Romania Cardiomed Health SRL Timisoara
Romania Medicalife Tim SRL Timisoara
Romania Mornos Cristian Medic Independent Timisoara
Romania Policlinica Dr. Tudoran Timisoara
Romania CMI Tatar A. Maria Cristina, CUI 19814204 Tirgu Mures
Romania German Sallo Marta - Medic primar cardiolog, CIF 35699735 Tirgu Mures
Romania Bendl H. Laura Elena - Cabinet Medical Individual Plus Clinic Turnu Severin
Romania Croitoru G Rodica Medic Colaborator Valea Adinca
Romania CMI Demle S. Adriana-Cristina Zalau
Romania Dr. Dragos Lupu - Medic Specialist Cardiolog Zarnesti
Switzerland Universitätsspital Basel Basel
Switzerland Engeried-Spital (Bern) Bern
Switzerland Spital Sonnenhof Bern
Switzerland Spitalzentrum Biel Biel
Switzerland Hôpital de La Tour Carouge
Switzerland Cardiomed - Jura Courrendlin
Switzerland Centre de Cardiologie Delémont
Switzerland Schlossberg Ärztezentrum Frauenfeld
Switzerland Hôpitaux Universitaires de Genève Geneva 14
Switzerland Hôpitaux Universitaires de Genève Genève
Switzerland Hôpitaux Universitaires de Genève Genève 14
Switzerland Spital Lachen AG Lachen
Switzerland CHUV-Centre hospitalier universitaire vaudois Lausanne
Switzerland Herzzentrum Hirslanden Zentralschweiz Luzern
Switzerland Luzerner Kantonsspital Luzern
Switzerland Hôpital de Morges Morges
Switzerland Dr. med. Eleni Goulouti Neuchâtel
Switzerland Kantonsspital Olten Olten
Switzerland Herzpraxis Regensdorf Regensdorf
Switzerland Kantonsspital Obwalden Sarnen
Switzerland Rehaklinik Seewis Seewis
Switzerland Dr. med. Kiril Tzvetanov Sierre
Switzerland Herzpraxis Sankt Gallen St. Gallen
Switzerland Herzpraxis Sursee Sursee
Switzerland Kardiologie Aarezentrum Thun Thun
Switzerland Spital STS AG Thun
Switzerland Hôpital Fribourgeois Villars-sur-Glâne
Switzerland Herz- und Physiozentrum Wallisellen
Switzerland Arztpraxis Waltenschwil Waltenschwil
Switzerland Spital Will Will
Switzerland Herz- und Kreislaufpraxis Winterthur Winterthur
Switzerland Medbase Winterthur Neuwiesen Winterthur
Switzerland Hôpital d'Yverdon-les-Bains Yverdon-les-Bains
Switzerland Spital Zollikerberg Zollikerberg
Switzerland Gruppenpraxis Dr. Deseö / Dr. Deseö-Schütz / Dr. Lorger Zürich
Switzerland Herzklinik Hirslanden Zürich
Switzerland HerzKlinik Zürich Hirslanden Zürich
Switzerland Herzkreislaufpraxis Zürich
Switzerland Herzpraxis Enge ZH Zürich
Switzerland SICADE Clinic Zürich
Switzerland Universitätsspital Zürich Zürich

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Hungary,  Poland,  Romania,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Kansas City Cardiomyopathy Questionnaire (KCCQ) - Clinical summary score (CSS) in patients treated with empagliflozin KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. The score is transformed to a range of 0 - 100, in which higher scores reflect better health status. At baseline, at week 24.
Primary Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score (TSS) in patients treated with empagliflozin KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-TSS incorporates the symptom frequency (4 items) and symptom burden (3 items) domains into a single summary score. The score is transformed to a range of 0-100, in which a higher score reflects better health status. At baseline, at week 24.
Primary Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (OSS) 1 in patients treated with empagliflozin KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ-OSS incorporates all domains into a score, ranging from 0-100, in which a higher score reflects better health status. At baseline, at week 24.
Secondary Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin Change of the New York Heart Association (NYHA) Class in patients treated with empagliflozin. At baseline, at week 24.
Secondary Patient characteristics To evaluate patient characteristics in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). At baseline.
Secondary Frequency of comorbidities To evaluate the frequency of comorbidities in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). At baseline.
Secondary Treatment patterns To evaluate treatment patterns in participants with chronic Heart Failure with reduced Ejection Fraction (HFrEF). At baseline.
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