Heart FailureNCT05350202
Emp-Activity: Empagliflozin Functional Capacity
An observational study of Heart Failure, run by Boehringer Ingelheim at 350 sites in 6 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Empagliflozin
- How many people
- 3,431 participants
- Where
- 350 sitesin 6 countries
- Study dates
- 18 Dec 2022to 25 Jul 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
350 sites in 6 countries.
350 sites in 6 countries
Poland115 sites
ECHOKardio Poradnia Kardiologiczna
Bialystok, 15-028
Klinika Kardiologii Uniwersyteckiego Szpitala Klinicznego w Białymstoku
Bialystok, 15-276
Kardiologiczna Praktyka Lekarska Anna Tomaszuk-Kazberuk
Bialystok, 15-546
Podlaski Ośrodek Kardiologii
Bialystok, 15-875
Specjalistyczna Praktyka Lekarska Marek Styczkiewicz
Brzozów, 36-200
BlueMed - Centrum Medyczne
Bydgoszcz, 85-088
Centrum Kardiologii Paweł Grzelakowski
Bydgoszcz, 85-095
Centrum Medyczne A i D Nowak sj
Bydgoszcz, 85-314
Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Ługowski
Bydgoszcz, 85-791
Specjalistyczna Praktyka Lekarska Grzegorz Grześk
Bydgoszcz, 85-796
Indywidualna Specjalistyczna Praktyka Lekarska Jolanta Nowak
Bytom, 41-902
Specjalistyczna Praktyka Lekarska Agata Fenger
Chorozow, 41500
Med. - Zone sp zoo
Cieszyn, 43-400
Specjalistyczna Praktyka Lekarska lek.n.med.Lucyna Góras-Hetmańczyk
Czeladź, 41250
Gabinet Kardiologiczny - Jacek Jafra
Częstochowa, 42-202
Prywatna Praktyka Lekarska Artur Dekiela
Częstochowa, 42-202
Specjalistyczna Praktyka Lekarska Magdalena Miczko
Dąbrowa Górnicza, 41-300
ISPL Małgorzata Dobrowolska Gabinet Tendo
Gdynia, 81-395
Specjalistyczna Praktyka Lekarska Wojciech Czapla
Gliwice, 44-100
Miedziowe Centrum Zdrowia S.A.
Głogów, 67-200
Centrum Medyczne NIWA
Głogów Małopolski, 36-060
Dorota Adamczyk-Kot NZOZ-KARDIO
Gmina Jędrzejów, 28-300
Lekarze na Dworskiej
Gmina Świebodzin, 66-200
Indywidualna Praktyka Lekarska Tomasz Zieliński
Grodzisk Mazowiecki, 05-825
Przychodnia Lekarska Zdrowy Miś
Grójec, 05-600
Indywidualna Praktyka Lekarska Piotr Tokarczyk
Inowrocław, 88-100
Familia Medicina Sp. z o.o.
Iwanowice Włościańskie, 32-095
Specjalistyczna Praktyka Lekarska Jarosław Paździerz
Jasło, 38-200
Specjalistyczna Praktyka Lekarska Urszula Winiarska-Waluś
Jastrzębie Zdrój, 44-330
Centrum Medyczne Kinesis
Kamień, 36-053
Praktyka Lekarska Wojciech Kwaśniewski
Katowice, 40-645
Prywatna Przychodnia Specjalistyczna Drozd Zbigniew Gąsior
Katowice, ul. Drozdów 26
CUM PromontMed
Kielce, 25-020
Arsmedica Specjalistyczna Praktyka Lekarska lek.med. Krzysztof Czerniejewski
Konin, 62-500
Prywatny Gabinet Kardiologiczny lek. med. Sławomir Kępski
Konin, 62-500
Specjalistyczna Praktyka Lekarska Paweł Michalski
Konin, 62-500
Uromed Sp Zoo
Koszalin, 75-402
Poliklinika MSWiA/Indywidualna Specjalistyczna Praktyka Lekarska Krzysztof Jarząbek
Koszalin, 75-604
Indywidualna Praktyka Lekarska Krzysztof Maślak
Koźminek, 62-840
Centrum Medyczne Dietla 19 sp. Z o.o.
Krakow, 31-070
Centrum Twojego Zdrowia
Krakow, 31-101
Specjalistyczna Praktyka Lekarska "Kardiolek" Dr med. Piotr Wilkołek
Krakow, 31-216
CM Oficerskie
Krakow, 31-513
Poradnia Kardiologiczna, Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, 31-826
Prywatny Gabinet Kardiologiczny Dr n.med Janusz Bąk
Kranse, 36-007
Centrum Medyczne Dębina
Krościenko Wyżne, 38-422
Poradnia Kardiologiczna Centrum Medyczne w Łańcucie
Łańcut, 37-100
SP ZOZ Łęczna
Łęczna, 21-010
Beata Mikłaszewicz&Dariusz Dąbrowski Cardiamed S.J.
Legnica, 59-220
NZOZ DUOMED S.C. Poradnia Kardiologiczna
Legnica, 59-220
Prywatny Specjalistyczny Gabinet Kardiologiczno-Internistyczny
Libiąż, 32-590
Santa Sp. z o.o.
Lodz, 90-302
Nzoz Salusmed
Lodz, 91-002
Kardiologiczna Praktyka Lekarska Wojciech Kula
Lublin, 20-053
NZOZ Sanus Jacek Madej Poradnia kardiologiczna
Lublin, 20-143
NZOZ Sanus Jacek Madej
Lublin, 20-143
Provivo Specjalistyczne Centrum Medyczne
Lublin, 20-400
Indywidualna Specjalistyczna Praktyka Lekarska - Renata Leniec
Lublin, 59-300
Kardiologiczno - Internistyczny Gabinet Lekarski Skrzyński Andrzej
Łuków, 21-400
Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczne Gabinety lekarskie
Mikołów, 43-190
Gabinet Lekarski Kardiologiczny
Mirków, 55-095
Prywatne Usługi Medyczne Jacek Morka
Modliszewice, 26-200
Indywidualna Specjalistyczna PraktyKa Lekarska-Piotr Utz
Moszczenica, 97-310
Gabinet Lekarski Ewa Burchard
Nowe Miasto nad Pilicą, 26-420
Medyczne Centrum Zdrovita
Nowy Tomyśl, 64-300
Oleśnica Prywatna Praktyka Lekarska
Oleśnica, 56-400
SZOZ Jantar Sp. z o.o. Poradnia Lekarzy Specjalistów
Ostrów Wielkopolski, 63-400
GVM CARINT Oświęcim
Oświęcim, 32-600
Specjalistyczna Praktyka Lekarska Rafał Nowak
Piasek, 43-211
Specjalistyczna Praktyka Lekarska Andrzej Bęben
Piotrkow Trybunalski, 97-300
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Strawczyński
Płock, 09-402
Indywidualna Specjalistyczna Praktyka Lekarska Andrzej Bolewski
Poznan, 60-461
Wojewódzki Szpital im. św. Ojca Pio w Przemyślu
Przemyśl, 37-700
Leszek Kaminski Specjalistyczny Gabinet Lekarski
Przeworsk, 37-200
Praktyka Lekarska Katarzyna Czarnecka
Pszczyna, 43-200
PCK - Puławskie Centrum Kardiologiczne Przychodnia Specjalistyczna
Puławy, 24-100
Poradnia Kardiologiczna SPZOZ Pulawy
Puławy, 24-100
Indywidualna Specjalistyczna Praktyka Lekarska Magdalena Poterala
Radom, 26-600
Poradnia Kardioogiczna Zegara Słonecznego
Radom, 26-600
Specjalistyczna Praktyka Lekarska Radzionków
Radzionków, 41-922
Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Alicja Gałuszka-Bilińska
Rybnik, 44-203
Specjalistyczna Praktyka Lekarska Wiesława Faberska-Blicharska
Rybnik, 44-217
Centrum Medyczne Sabamed
Rzeszów, 35-006
Prywatny Gabinet Kardiologiczny dr n.med Janusz Romanek
Rzeszów, 35-055
My Life Centrum chorób serca
Sanok, 38-500
Specjalistyczna Praktyka Lekarska Kamila Stembalska
Ścinawa, 59-330
Monika Kujawiak Prywatna Praktyka Lekarska
Siedlce, 08-110
Prywatny Gabinet Lekarski Hanna Wilk-Manowiec
Siedlce, 08-110
Indywidualna praktyka lekarska Artur Marcinkiewicz
Siemianowice Śląskie, 41-106
Asnyka 78d Gabinety Lekarskie
Skierniewice, 96-100
Specjalistyczna Praktyka Lekarska Maciej Kaźmierski
Sosnowiec, 41-200
Specjalistyczna Praktyka Lekarska Marek Kondys
Sosnowiec, 41-200
Powiatowy Szpital Specjalistyczny w Stalowej Woli
Stalowa Wola, 37-450
Centrum Medyczne VITA
Szczecin, 70-341
Specjalistyczna Praktyka Lekarska Tomasz Urbanik
Szczecin, 71-790
ISPL Anna Bis
Szczecin, 71-804
Szpital w Szczecinku
Szczecinek, 78-400
Gabinet Lekarski Weronika Greberska
Szczytniki, 62-023
Specjalistyczna Praktyka Lekarska Paweł Kocik
Tarnów, 33-100
Leomed Centrum Medyczne
Tarnowskie Góry, 42-606
Prywatna Praktyka Lekarska na wezwanie Mirosław Marciniak
Torun, 87-100
Indywidualna Specjalistyczna Praktyka Lekarska - Witold Orszulak
Tychy, 43-100
Urszula Urbanowicz Specjalistyczna Praktyka Lekarska
Tychy, 43100
Centrum Medyczne Nowe Miasto
Wałbrzych, 58-302
SERCE S.C. Przychodnia Lekarzy Specjalistów
Warsaw, 02-496
Klinika 37 Centrum Kardiologii Płowiecka
Warsaw, 02-991
Prywatny Gabinet Lekarski Bożena Norwa-Otto
Warsaw, 04-188
Gabinet Lekarski lek med. Robert Włodarczyk
Wawrzeńczyce, 32-125
Specjalistyczny Gabinet Lekarski Łukasz Graczykowski
Włocławek, 87-800
Specjalistyczna Prajtyka Lekarska Grażyna Glanowska
Zabrze, 10444
Gabinet Prywatnej Praktyki Lekarskiej Kard.-Int . Dr n.med. Brygida Przywara-Chowaniec
Zabrze, 41-800
Ns Zoz Kardiologia Sp. Z.O.O.
Zamość, 22-400
Gabinety Lekarskie JM Kulczyccy
Żary, 68-200
ALDEMED Centrum Medyczne
Zielona Góra, 65-001
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, 96-300
Romania106 sites
Miclea Ioana - Mariana MEDIC SPECIALIST CARDIOLOG
Alba Iulia, 510137
Dr. Morar Mihnea-Dragoscabinet Medical Individual - Specialist Cardiologie
Arad, 310009
Dr. Pop-Moldovan Adina-Ligia - Medicina Interna - Cardiologie
Arad, 310182
CMI Iosipescu Laura Cristina
Bacau, 600037
Cardio Animus SRL
Bacau, 600204
CMI - Centrul medical Diacord
Baia Mare, 430076
Mercea Corina-Delia - Medic
Baia Mare, 430123
Ambrinomed SRL
Botoșani, 710095
Cardioland SRL
Brasov, 500326
Rus V. Horatiu - Cabinet Medical Individual de Cardiologie
Brasov, RO-500188
S.C. Ilro Medical S.R.L
Bucharest, 010991
PFA Balahura Cristian
Bucharest, 011026
Dr. Danet Ruxandra - Medic Cardiologie
Bucharest, 011258
Dr. Bogdan Stefan Nicolae
Bucharest, 011925
Cardiocare Center SRL
Bucharest, 012052
Cordmedica SRL
Bucharest, 012082
Dr. Serban Irina-Ruxandra - MEDIC PRIMAR CARDIOLOGIE
Bucharest, 020281
Urocard Plus Srl
Bucharest, 020281
Medi Pro Consult SRL
Bucharest, 020501
Cmi Dr Georgescu Dragos
Bucharest, 021705
Dr. Geavlete Dana-Oliviana - Activitate Medicala
Bucharest, 021967
Mihaila I. Sorina - Medic Pfi
Bucharest, 030915
S.C. Cardiomedical Team Pro S.R.L.
Bucharest, 040343
Dumitrescu Silviu-Ionel Persoana Fizica Autorizata
Bucharest, 060926
Mihalcea Janina-Diana Medic Specialist Cardiologie
Bucharest, 061192
Patrascu R. Natalia - Medic Specialist Medicina Interna
Bucharest, 061304
Popescu I. Ileana Nicoleta Medic specialist cardiologie
Bucharest, 061406
CMI Dr. Parsa Motlagh Babak
Bucharest, 062282
Magister Research SRL
Bucharest, 070000
Dr. Lungeanu-Juravle Laura-Activitate Medicala
Bucharest, RO-011038
Cardio Clinique NCS SRL
Buzău, 120195
Medcon SRL
Buzău, 120203
Medicard SRL
Buzău, 120279
Angioplast Medical srl
Ciurea, RO-707085
CMI Diaconescu Iulia Dana
Cluj-Napoca, 400347
Mediprax Centrum Cluj Napoca
Cluj-Napoca, 400347
SC Adisan SRL
Cluj-Napoca, 400347
Sc Medicardio Andreea Srl
Cluj-Napoca, 400347
Cardiotreat SRL
Cluj-Napoca, 400349
SC Clujana Medica Srl
Cluj-Napoca, 400394
PFA Comsa M.Dan-Horatiu
Cluj-Napoca, 400441
Cabinet Cardiohealt Srl
Cluj-Napoca, 400479
SC Cardioprotect MED SRL
Cluj-Napoca, 400535
Sc Dentcor Srl
Cluj-Napoca, RO-400480
Cardio World Health
Com Mosoaia, 117512
Cardio Manea Adelina SRL
Constanța, 610219
Endodiahealth Srl
Constanța, 900002
Dr. Maxim George Razvan - Activitate Medicala
Constanța, 900168
CMI Dr Ilie Ivona Valeria
Constanța, 900519
Asclepios Medicalhealth SRL
Constanța, 900615
Sc Daxiela Impex Srl
Craiova, 200085
Hortopan Med SRL
Craiova, 200323
Neurocord Medical Srl
Craiova, 200383
Vesalius Medical S.R.L
Craiova, 200470
Cabinet Medical Individual - Dr. Popescu Monica
Craiova, 200519
SC A&C Medical Prime SRL
Craiova, RO-200692
S & R Cardiobalance Srl
Curtea de Argeş, 115300
Cardiolife
Deva, 330011
Bendl H. Laura Elena - Cabinet Medical Individual Plus Clinic
Drobeta-Turnu Severin, 220004
SC Maycor SRL
Galati, 800217
CMI Dr. Chiscaneanu Teodor
Galati, 800584
Cardiomedplus SRL
Gheorghieni, 535500
Procardia Serv-Med 2009 SRL srl
Iași, 700111
Sc Cardiocare Clinic Srl
Iași, 700260
Sc Cardiortomed Srl
Iași, 700282
Medical Cardio Anghel SRL
Iași, 700451
Niculescu G. Ana Irina - Medic colaborator
Iași, 700688
SC Cardiomed SRL Iasi
Iași, 700732
Cardioszakacs Srl, Cui 34404518
Miercurea-Ciuc, 530112
Polimed Center SRL, CUI 26072639
Odorheiu Secuiesc, 535600
CMI Dr. Rotariu Dragos
Oradea, 410009
CMI Societatea civila Magheru&Magheru
Oradea, 410027
CMI Cardiomed SRL
Oradea, 410169
PFA Dr. Ardelean Adriana Ioana
Oradea, 410388
Dradiand SRL
Oradea, 410473
Sc Adriacard Srl
Oradea, 410474
Simed Concept SRL
Ostratu, 012052
Andries I. Elena - Medic Primar Cardiologie Si Medic Specialist Mi
Piatra Neamţ, 610065
Cardiomed Alexandrescu Srl-D
Piatra Neamţ, 610078
Dr. Corcoz Cardiologie SRL
Piatra Neamţ, 610150
Davisof San Srl
Piteşti, 110003
Clinica Cardiologie Dr Stanciu Viorel
Piteşti, 110074
Sc Procordia Concept Srl
Piteşti, 110172
Cavi Clinique SRL
Ploieşti, 100562
SC Cardiologie Dr. Cristina Radoi SRL
Râmnicu Vâlcea, 240022
Sc Lidermed Plus Srl
Râmnicu Vâlcea, 240282
Sc Incarmed Srl
Râmnicu Vâlcea, 240284
Gx.Hatconsulting Srl
Săcele, 505600
Cardio Stim Center SRL
Sânpetru, 507190
Munteanu Alice-Elena - Medic Cardiolog
Sat Rosu, Comuna Chiajna, 077041
Voineag Olivia Medic Colaborator
Scheia, 720282
Batar D. Sergiu Constantin
Şelimbăr, 557260
SC Endocordis SRL
Sfântu Gheorghe, 520068
Rusu N. Ramona Iulia Medic Primar Cardiologie
Suceava, 720067
German Sallo Marta - Medic primar cardiolog, CIF 35699735
Târgu Mureş, 540095
CMI Tatar A. Maria Cristina, CUI 19814204
Târgu Mureş, RO-540496
Diaconu Diana - Medic Cif 31885867
Tifgu Mures, 540281
Cardiomed Health SRL
Timișoara, 300172
Mornos Cristian Medic Independent
Timișoara, 300230
Cardio Suport SRL
Timișoara, 300244
Medicalife Tim SRL
Timișoara, 300362
Cardio - DRS S.R.L
Timișoara, 300369
Policlinica Dr. Tudoran
Timișoara, 300480
Croitoru G Rodica Medic Colaborator
Valea Adâncă, 700732
CMI Demle S. Adriana-Cristina
Zalău, 450103
Dr. Dragos Lupu - Medic Specialist Cardiolog
Zarnesti, 505800
Czechia41 sites
MUDr. Hana Burianová
Bílovec, 743 01
Fakultní nemocnice u sv. Anny v Brně
Brno, 602 00
MUDr. Karel Kameník s.r.o.
Brno, 603 00
MUDr. Libor Nechvátal s.r.o.
Brno, 61600
Zdravá srdce s.r.o.
Brno, 62700
Kardiologická ambulance Brno, s.r.o.
Brno-Královo Pole, 61200
EDUMED s.r.o. - Dr. Nováková
Broumov, 55001
EDUMED s.r.o. - Dr. Polášková
Broumov, 55001
EDUMED s.r.o. - Dr. Švarcová
Broumov, 55001
EDUMED s.r.o.
Broumov, 55001
Kardiologická ambulance Český krumlov
Český Krumlov, 38101
CorMedico s.r.o.
Frýdek-Místek, 73801
DIKa centrum s.r.o.
Havířov, 73601
Lékařský servis, a.s.
Havířov, 73601
Kardio Pudich s.r.o.
Hlučín, 748 01
ProKardio HK, s.r.o.
Hradec Králové, 50011
Nemocnice Jihlava - Kardiologické oddělení
Jihlava, 58633
Oblastní nemocnice Kolín, a.s. nemocnice Středočeského kraje
Kolín, 2802
KardioBušák s.r.o.
Louny, 440 01
Kardiomost s.r.o.
Most, 43401
Nemocnice AGEL Nový Jičín, a.s.
Nový Jičín, 74101
Kardiologická ambulance Olomouc
Olomouc, 77900
Nemocnice AGEL Ostrava-Vítkovice a.s. - Kardiologická ambulance
Ostrava, 70030
Kardiologická ambulance Mammed
Ostrava, 70200
OVAKARD s.r.o.
Ostrava, 70200
Poliklinika Nová Huť
Ostrava, 71900
Fakultní nemocnice Ostrava
Ostrava - Poruba, 708 52
Kardiologie Vinohrady s.r.o.
Prague, 120 00
Kardiologie prof. Táborský s.r.o.
Prague, 12000
Vseobecna fakultni nemocnice v Praze
Prague, 128 00
MEDICON a.s.
Prague, 140 00
Nemocnice na Homolce
Prague, 150 30
Clinical Trials Service s.r.o.
Prague, 15600
ROcardia s.r.o.
Prostějov, 79604
Galenica Medical s.r.o.
Prostřední Suchá, 73564
KARDIO GRÉZL, s.r.o.
Šumperk, 78701
Všeobecná interní ambulance s.r.o.
Tábor, 39003
Nemocnice AGEL Třinec-Podlesí a.s.
Třinec Podlesí, 73961
Kardiologická ambulance MUDr. Ferkl s.r.o.
Trutnov, 54101
Lunacor s.r.o.
Vizovice, 76312
Krajská nemocnice T. Bati, a.s.
Zlín, 76275
Switzerland40 sites
Universitätsspital Basel
Basel, 4051
Spital Sonnenhof
Bern, 3006
Engeried-Spital (Bern)
Bern, 3012
Spitalzentrum Biel
Biel, 2501
Hôpital de La Tour
Carouge, 1227
Cardiomed - Jura
Courrendlin, 2830
Centre de Cardiologie
Delémont, 2800
Schlossberg Ärztezentrum
Frauenfeld, 8500
Hôpitaux Universitaires de Genève
Geneva, 1205
Hôpitaux Universitaires de Genève
Geneva, 1211
Spital Lachen AG
Lachen, 8853
CHUV-Centre hospitalier universitaire vaudois
Lausanne, 1011
Luzerner Kantonsspital
Lucerne, 6004
Herzzentrum Hirslanden Zentralschweiz
Lucerne, 6006
Hôpital de Morges
Morges, 1110
Dr. med. Eleni Goulouti
Neuchâtel, 2000
Kantonsspital Olten
Olten, 4600
Herzpraxis Regensdorf
Regensdorf, 8105
Herzpraxis Sankt Gallen
Sankt Gallen, 9000
Kantonsspital Obwalden
Sarnen, 6060
Rehaklinik Seewis
Seewis, 7212
Dr. med. Kiril Tzvetanov
Sierre, 3960
Herzpraxis Sursee
Sursee, 6210
Kardiologie Aarezentrum Thun
Thun, 3600
Spital STS AG
Thun, 3600
Hôpital Fribourgeois
Villars-sur-Glâne, 1752
Herz- und Physiozentrum
Wallisellen, 8304
Arztpraxis Waltenschwil
Waltenschwil, 5622
Spital Will
Will, 9500
Herz- und Kreislaufpraxis Winterthur
Winterthur, 8400
Medbase Winterthur Neuwiesen
Winterthur, 8400
Hôpital d'Yverdon-les-Bains
Yverdon-les-Bains, 1400
Spital Zollikerberg
Zollikerberg, 8125
SICADE Clinic
Zurich, 8001
Herzpraxis Enge ZH
Zurich, 8002
Gruppenpraxis Dr. Deseö / Dr. Deseö-Schütz / Dr. Lorger
Zurich, 8008
Herzklinik Hirslanden
Zurich, 8032
HerzKlinik Zürich Hirslanden
Zurich, 8032
Herzkreislaufpraxis
Zurich, 8055
Universitätsspital Zürich
Zurich, 8091
Bulgaria35 sites
Dr. Mircheva
Burgas, 8000
Dr. Yordanov
Haskovo, 6304
MBAL Atanas Dafovski, Kardzhali
Kardzhali, 6600
Dr. Krasteva
Kyustendil, 2501
Dr. Todorov
Lovech, 5500
Dr. Tsoneva
Lovech, 5500
Dr. Pavlov
Parvomay, 4270
Medical Center, Pazardjik
Pazardzhik, 4400
Dr. Stankova
Pernik, 2300
assoc.prof. Gospodinov
Pleven, 5800
dr. Kostadinovska
Pleven, 5800
prof.Tisheva
Pleven, 5800
Dr. Mekenian
Plovdiv, 4001
Dr. Ilchev
Plovdiv, 4002
Dr. Hairabedian
Plovdiv, 4018
Dr. Filipov
Plovdiv, 4020
MBAL Sliven, Dr. Bletsova
Sliven, 8800
Dr. Pancheva
Sofia, 1000
prof. Velchev
Sofia, 1000
dr. Georgieva
Sofia, 1202
dr. Karchinova
Sofia, 1202
prof.Vitlianova
Sofia, 1202
dr. Petrusheva
Sofia, 1233
dr. Garvanski
Sofia, 1407
Dr. Naidenova
Sofia, 1431
Dr. Varnaliiska
Sofia, 1431
prof. Karamfiloff
Sofia, 1431
Dr. Nossikov
Sofia, 1784
Dr. Gospodinov
Stara Zagora, 6004
Dr. Trendafilova
Targovishte, 7700
dr. Belcheva
Varna, 9000
dr. Mancheva
Varna, 9003
dr. Gyuzelev
Varna, 9010
Dr. Petrova
Yambol, 8600
Dr. Toneva-Zhelaeva
Yambol, 8600
Hungary13 sites
Állami Szívkórház
Balatonfüred, 8230
Gottsegen György National Cardiovascular Center
Budapest, 1096
Heart and Vascular Centre, Semmelweis University
Budapest, 1122
Sante Cons Bt.
Budapest, 1133
DE Klinikai Központ Kardiológia és Szívsebészet
Debrecen, 4032
Dombóvári Szent Lukács Kórház
Dombóvár, 7200
Lahynara Bt
Dunavarsány, 2336
Kardiológia Magánrendelő
Eger, 3300
Mohácsi Kórház
Mohács, 7700
Coromed-Smo
Pécs, 7623
University of Pécs
Pécs, 7624
Soproni Erzsébet Oktató Kórház
Sopron, 9400
Újszeged Egészségközpont
Szeged, 6726
About this study
Official title: Empagliflozin Functional Capacity - Non-Interventional Study
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.
- Conditions
- Heart Failure
- Being tested
- Empagliflozin
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
Also called Jardiance®
Empagliflozin was administered according to the approved product information.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin-treated patients | Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg). Receives: Drug: Empagliflozin | |
| Non-SGLT2i-treated patients | Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as [Week 24] - [Baseline]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.
Measured: At baseline and at week 24.
Secondary outcomes (4)
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
This outcome measured the number of patients newly treated with empagliflozin who experienced a change in the New York Heart Association (NYHA) Class from baseline to Week 24. The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort.
Measured: At baseline and at Week 24.
Number of Participants With Comorbidities
Number of patients with first prescription of empagliflozin and patients prescribed drugs other than SGLT2 inhibitors with concomitant disease/comorbidities. Concomitant diseases/comorbidities are presented according to the ICD-10-CM (the International Classification of Diseases, Tenth Revision, Clinical Modification) standardized system using the disease code.
Measured: At baseline.
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Number of patients who took concomitant HF-related medication.
Measured: At baseline.
Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline
Number of patients hospitalized at least one time due to heart failure (HF).
Measured: Up to 6 months prior to baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start18 Dec 2022
- Primary completion25 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350202
- Sponsor's protocol ID
- 1245-0259
- Status last verified
- Aug 2025
- First submitted
- 22 Apr 2022
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin Functional Capacity - Non-Interventional Study
- ClinicalTrials.gov ID
- NCT05350202
- Acronym / sponsor ID
- 1245-0259
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,431 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 25 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin-treated patients | – | Drug: EmpagliflozinPatients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg). |
| Non-SGLT2i-treated patients | – | –Patients with heart failure (HF), with or without diabetes, who received drugs with mechanisms of action other than empagliflozin (drugs other than SGLT2i (Sodium-Glucose Co-Transporter 2 inhibitors)) were treated according to the approved product information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmpagliflozinAlso: Jardiance®Empagliflozin was administered according to the approved product information. | Drug | Empagliflozin-treated patients |
Primary outcome
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice
Time frame: At baseline and at week 24.
Change from baseline to Week 24 of the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, calculated as [Week 24] - [Baseline]. The KCCQ includes 23 items across 7 domains: physical limitation, symptom stability, symptom frequency, symptom burden, self-efficacy, quality of life, and social limitation. This outcome measured the total symptom score (TTS), clinical summary score (CSS), and overall summary score (OSS) in the empagliflozin-treated patients as defined in the clinical study protocol. The TTS evaluates symptom frequency and burden and is calculated as the mean of the symptom frequency score and symptom burden score. The CSS is calculated as the mean of the physical limitation score and total symptom score. The OSS is calculated as the mean of the physical limitation score, total symptom score, quality of life score, and social limitation score. The TTS, CSS, and OSS are represented on a 0-to-100-point scale, where a higher score reflects better health status.
4 secondary outcomes
Change of the New York Heart Association (NYHA) Class in Patients Newly Treated With Empagliflozin
Time frame: At baseline and at Week 24.
Number of Participants With Comorbidities
Time frame: At baseline.
Number of Participants With Concomitant Heart-failure (HF) Related Medication
Time frame: At baseline.
Hospitalizations Due to Heart-failure in the Past 6 Months Before Baseline
Time frame: Up to 6 months prior to baseline visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Related trials for Heart Failure
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Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
350 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boehringer Ingelheim at 350 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 350 sites in Poland, Romania, Czechia, Switzerland, Bulgaria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Kansas City Cardiomyopathy Questionnaire (KCCQ) Scores in Patients Newly Treated With Empagliflozin According to Routine Practice (time frame: At baseline and at week 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.