Výzkumná studie zkoumající, jak ziltivekimab funguje ve srovnání s placebem u účastníků se srdečním selháním a zánětem (ATHENA)
30. září 2026 aktualizováno: Novo Nordisk A/S
Účinky ziltivekimabu versus placebo na příznaky srdečního selhání a fyzické funkce u pacientů se srdečním selháním s mírně sníženou nebo zachovanou ejekční frakcí a systémovým zánětem
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
Přehled studie
Postavení
Postavení
Aktivní, ne nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
673
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
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Buenos Aires, Argentina, C1119ACN
- CIPREC Pueyrredon
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CABA, Argentina, C1061AAS
- CIPREC Arenales
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Esperanza, Santa Fe, Argentina, S3080BQV
- Sanatorio Esperanza
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Morón, Argentina, B1708IFF
- Consultorio Integral de Atención al Diabético
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Salta, Argentina, 4400
- Centro Cardiovascular Salta
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San Miguel de Tucumán, Tucumán., Argentina, T4000
- Investigaciones Clinicas Tucuman
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Buenos Aires
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City of Buenos Aires, Buenos Aires, Argentina, C1425
- Cardiología Palermo
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Lanús Este, Buenos Aires, Argentina, B1824KAJ
- Centro Médico CIMEL
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Australian Capital Territory
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Garran, Australian Capital Territory, Austrálie, 2605
- Canberra Hospital
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New South Wales
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New Lambton Heights, New South Wales, Austrálie, 2305
- John Hunter Hospital
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New Lambton Heights, New South Wales, Austrálie, 2305
- John Hunter Hospital - Cardiovascular Department
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Wollongong, New South Wales, Austrálie, 2500
- Illawarra Heart Health Centre
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Queensland
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Brisbane, Queensland, Austrálie, 4032
- The Prince Charles Hospital
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Chermside, Queensland, Austrálie, 4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
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Victoria
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Ballarat, Victoria, Austrálie, 3350
- Ballarat Base Hospital
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Epping, Victoria, Austrálie, 3076
- The Cardiologists Pty Ltd
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Epping, Victoria, Austrálie, 3076
- Northern Private Hospital Epping - The Cardiologists
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Mulgrave, Victoria, Austrálie, 3170
- Advara HeartCare Mulgrave
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Mulgrave, Victoria, Austrálie, 3170
- Advara HeartCare
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Western Australia
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Murdoch, Western Australia, Austrálie, 6150
- Fiona Stanley Hospital Cardiology
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Blagoevgrad, Bulharsko, 2700
- MHAT Puls AD, Cardiology Department
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Haskovo, Bulharsko, 6300
- MHAT Haskovo AD
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Pleven, Bulharsko, 5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
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Plovdiv, Bulharsko, 4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
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Sofia, Bulharsko, 1784
- Medical Center Synexus Sofia EOOD
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Sofia, Bulharsko, 1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
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Sofia, Bulharsko, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulharsko, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, Bulharsko, 1606
- UMHATEM N.I. Pirogov EAD
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Chambray-lès-Tours, Francie, 37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
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Poitiers, Francie, 86000
- Centre Hospitalier Universitaire de Poitiers
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Rennes, Francie, 35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francie, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
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Toulon, Francie, 83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
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Valenciennes, Francie, 59300
- Polyclinique Vauban
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Vandœuvre-lès-Nancy, Francie, 54500
- Chru de Nancy - Hopital Brabois
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, Indie, 520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Visakhapatnam, Andhra Pradesh, Indie, 530002
- King George Hospital
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Gujarat
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Vadodara, Gujarat, Indie, 390022
- Rhythm Heart Institute
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Karnataka
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Belagavi, Karnataka, Indie, 590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
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Belagavi, Karnataka, Indie, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
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Bengaluru, Karnataka, Indie, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, Indie, 560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
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Mysuru, Karnataka, Indie, 570015
- Manipal Hospital, Mysuru
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Udupi, Karnataka, Indie, 576104
- Kasturba Medical College and Hospital, Manipal
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Maharashtra
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Nagpur, Maharashtra, Indie, 441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
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Nagpur, Maharashtra, Indie, 440033
- Sengupta Hospital and Research Institute
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Nashik, Maharashtra, Indie, 422005
- Vijan Hospital & Research Centre
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Nashik, Maharashtra, Indie, 422005
- Chopda Medicare and Research Centre Pvt. Ltd.
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Pune, Maharashtra, Indie, 411028
- Villoo Poonawalla Memorial Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indie, 110029
- All India Institute of Medical Sciences (AIIMS)
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New Delhi, National Capital Territory of Delhi, Indie, 110060
- Sir Ganga Ram Hospital
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New Delhi, National Capital Territory of Delhi, Indie, 110002
- G B Pant Institute of Postgraduate Medical Education and Research
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New Delhi, National Capital Territory of Delhi, Indie, 110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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New Delhi, National Capital Territory of Delhi, Indie, 110093
- Rajiv Gandhi Super Speciality Hospital
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Odisha
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Bhubaneswar, Odisha, Indie, 751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Rajasthan
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Bikaner, Rajasthan, Indie, 334003
- S.P. Medical College & Associated Group of Hospitals
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Tamil Nadu
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Puducherry, Tamil Nadu, Indie, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
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Telangana
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Hyderabad, Telangana, Indie, 500020
- Guru Nanak CARE Hospitals
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Hyderabad, Telangana, Indie, 500055
- Malla Reddy Narayana Multispeciality Hospital
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Uttar Pradesh
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Aligarh, Uttar Pradesh, Indie, 202002
- Jawaharlal Nehru Medical College and Hospital
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Kanpur, Uttar Pradesh, Indie, 208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
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Lucknow, Uttar Pradesh, Indie, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Lucknow, Uttar Pradesh, Indie, 226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
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Utter Pradesh
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Aligarh, Utter Pradesh, Indie, 202002
- Jawaharlal Nehru Medical College and Hospital
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West Bengal
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Kolkata, West Bengal, Indie, 700027
- B M Birla Heart Research Centre
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Québec, Kanada, G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- University of Calgary_Calgary
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Ontario
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Cambridge, Ontario, Kanada, N1R 6V6
- Cambridge Cardiac Care Centre
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Cambridge, Ontario, Kanada, N1R 7R1
- Saul Vizel Pro. Med. Corp
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Scarborough Village, Ontario, Kanada, M1B 5N1
- Corcare Cardiovascular Research
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Toronto, Ontario, Kanada, M6G 1M2
- Diabetes Heart Research Centre
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Waterloo, Ontario, Kanada, N2T 0C1
- CPS Research
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Waterloo, Ontario, Kanada, N2T OC1
- Clinical Research Solutions Inc.
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Quebec
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Montreal, Quebec, Kanada, H1T 1C8
- Institut de Cardiologie de Montreal
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Montreal, Quebec, Kanada, H3G 1A4
- Montreal General Hospital
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Kota Bharu, Kelantan, Malajsie, 15586
- Hospital Raja Perempuan Zainab II
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Johor
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Johor Bahru, Johor, Malajsie, 80100
- Hospital Sultanah Aminah
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Kedah
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Alor Star, Kedah, Malajsie, 05460
- Hospital Sultanah Bahiyah
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Kelantan
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Kota Bharu, Kelantan, Malajsie, 15586
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre
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Lembah Pantai, Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malajsie, 25100
- Hospital Tengku Ampuan Afzan
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Perak
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Ipoh, Perak, Malajsie, 30450
- Hospital Raja Permaisuri Bainun Ipoh
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Selangor
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Kajang, Selangor, Malajsie, 43000
- Hospital Serdang
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Bremen, Německo, 28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
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Dresden, Německo, 01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
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Elsterwerda, Německo, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Erfurt, Německo, 99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
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Frankfurt, Německo, 60389
- MVZ CCB Frankfurt und Main-Taunus GbR
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Freiburg im Breisgau, Německo, 79106
- Universitätsklinikum Freiburg - Medical Center
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Fulda, Německo, 36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
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Homburg, Německo, 66421
- Universität des Saarlandes - Innere Med. III
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Kaiserslautern, Německo, 67655
- Kardiopraxis Schirmer
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Mainz, Německo, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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Bielsko-Biala, Polsko, 43-316
- American Heart of Poland S.A.
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Bydgoszcz, Polsko, 85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
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Gdynia, Polsko, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Lublin, Polsko, 20-601
- Zanamed Medical Clinic Sp. z o.o.
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Piotrkow Trybunalski, Polsko, 97-300
- Trialmed Sp. z o. o.
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Poznan, Polsko, 61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Tychy, Polsko, 43-100
- American Heart of Poland S.A.
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Warsaw, Polsko, 02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polsko, 85-605
- Centrum Medyczne Intercor Sp. z o.o.
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polsko, 87-800
- Kardio Life
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polsko, 87-800
- Kardio Life - Tomasz Borkowski
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polsko, 30-721
- Linden sp. z o.o. sp. k.
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Krakow, Lesser Poland Voivodeship, Polsko, 30-002
- Cardiomedicum Sp. z o.o.
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Oświęcim, Lesser Poland Voivodeship, Polsko, 32-600
- Formed 2 Sp. z o.o.
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Lower Silesian Voivodeship
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Jelenia Góra, Lower Silesian Voivodeship, Polsko, 58-506
- Pratia S.A.
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Wroclaw, Lower Silesian Voivodeship, Polsko, 50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Lublin Voivodeship
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Puławy, Lublin Voivodeship, Polsko, 24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
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Masovian Voivodeship
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Żyrardów, Masovian Voivodeship, Polsko, 96-300
- Prywatna Praktyka Lekarska Anna Chudoba
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polsko, 15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polsko, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
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Gdynia, Pomeranian Voivodeship, Polsko, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polsko, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
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Lodz, Łódź Voivodeship, Polsko, 90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
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Guilhufe - Penafiel, Portugalsko, 4560-136
- CHTâmega e Sousa - Hospital Padre Américo
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Lisbon, Portugalsko, 1500-650
- Hospital da Luz
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Lisbon, Portugalsko, 1649-035
- Centro Hospitalar Lisboa Norte
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Lisbon, Portugalsko, 1449-005
- CHLO, EPE - Hospital São Francisco Xavier
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Setúbal, Portugalsko, 2910-446
- Centro Hospitalar de Setubal
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Birmingham, Spojené království, B21 9RY
- FutureMeds
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Dundee, Spojené království, DD2 1GZ
- Ninewells Hospital
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Peterborough, Spojené království, PE3 9GZ
- Peterborough City Hospital
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Highland
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Inverness, Highland, Spojené království, IV2 3JH
- Raigmore Hospital
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West Sussex
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Chichester, West Sussex, Spojené království, PO19 6SE
- St. Richard's Hospital_Cardiology
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Alabama
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Alexander City, Alabama, Spojené státy, 35010
- Advanced Cardiovascular, LLC
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Fairhope, Alabama, Spojené státy, 36532
- Eastern Shore Rsrch Inst, LLC
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72204
- Cardiology & Medicine Clinic
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California
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Northridge, California, Spojené státy, 91325
- Valley Clinical Trials, Inc.
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Orange, California, Spojené státy, 92868
- UCI Health
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Pasadena, California, Spojené státy, 91105
- South California Heart Spc
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Florida
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Largo, Florida, Spojené státy, 33777
- Clearwater Cardiovascular Consultants
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Ocala, Florida, Spojené státy, 34471
- Ocala Cardiovascular Research
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Ormond Beach, Florida, Spojené státy, 32174
- Ormond Beach Clinical Research
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Saint Augustine, Florida, Spojené státy, 32086
- St Johns Ctr Clin Rsch-St. Aug
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Georgia
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Macon, Georgia, Spojené státy, 31201
- GA Arrhythmia Cons & Rsch Inst
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Savannah, Georgia, Spojené státy, 31406
- Velocity Clin Rsrch - Savannah
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Illinois
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Hazel Crest, Illinois, Spojené státy, 60429
- Chicago Medical Research LLC
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Kentucky
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Louisville, Kentucky, Spojené státy, 40202
- UofL Health Care Outpatient
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Maryland
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Baltimore, Maryland, Spojené státy, 21229
- Maryland Cardiovascular Specialists - Baltimore
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Oxon Hill, Maryland, Spojené státy, 20745
- MD Medical Research
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Michigan
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Bloomfield Hills, Michigan, Spojené státy, 48304
- Cardio and Vascular Assoc-CAVA
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Farmington Hills, Michigan, Spojené státy, 48334
- Millennium Cardiology
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Missouri
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Kansas City, Missouri, Spojené státy, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, Spojené státy, 63110
- Washington University
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Nevada
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Reno, Nevada, Spojené státy, 89502
- Renown Regional Medical Center
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New York
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Lake Success, New York, Spojené státy, 11042
- Long Island Cardiovascular Consultants PC
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New York, New York, Spojené státy, 10019
- Mount Sinai Hosp at NYC
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Riverhead, New York, Spojené státy, 11901
- Northwell Health Phys Cardio
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27599-7046
- University Of North Carolina At Chapel Hill
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Pennsylvania
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Horsham, Pennsylvania, Spojené státy, 19044
- AMS Cardiology
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Univ of Pennsylvania Hospital
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Texas
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Amarillo, Texas, Spojené státy, 79106
- PharmaTex Research
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Dallas, Texas, Spojené státy, 75390-9302
- University of Texas Southwestern Medical Center
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El Paso, Texas, Spojené státy, 79905
- David Turbay, MD, PLLC
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Katy, Texas, Spojené státy, 77493
- Private Practice Leadership LLC.
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San Antonio, Texas, Spojené státy, 78212
- Clinical Advancement Center
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San Antonio, Texas, Spojené státy, 78212
- Clinical Advancement Ctr, PLLC
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Sherman, Texas, Spojené státy, 75090
- Sherman Clinical Research
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Tomball, Texas, Spojené státy, 77375
- Northwest Heart Center
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Virginia
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Norfolk, Virginia, Spojené státy, 23507
- Sentara Health Research Center
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Richmond, Virginia, Spojené státy, 23219
- Virginia Commonwealth University
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Adana, Turecko (Türkiye), 01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
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Adana, Turecko (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Afyonkarahisar, Turecko (Türkiye), 03200
- Afyonkarahisar Health Sciences University
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Afyonkarahisar, Turecko (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
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Ankara, Turecko (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
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Ankara, Turecko (Türkiye), 06800
- Ankara Sehir Hastanesi Cardiology
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Bursa, Turecko (Türkiye), 16110
- Bursa Şehir Hastanesi- Kardiyoloji
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Edirne, Turecko (Türkiye), 22030
- Trakya University
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Edirne, Turecko (Türkiye), 22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
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Istanbul, Turecko (Türkiye), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
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Kayseri, Turecko (Türkiye), 38039
- Erciyes University Cardiology
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Kayseri, Turecko (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
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Kocaeli, Turecko (Türkiye), 41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
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Odunpazari
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Eskişehir, Odunpazari, Turecko (Türkiye), 26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
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Benešov, Česko, 256 01
- Innera s.r.o.
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Brno, Česko, 612 00
- Kardiologicka ambulance Brno s.r.o.
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Brno, Česko, 61500
- Vojenská nemocnice Brno p.o.
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Chomutov, Česko, 430 02
- Ordinace pro choroby srdce
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Prague, Česko, 170 00
- MEDICON a.s.
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Svitavy, Česko, 568 25
- Svitavska nemocnice Kardiologie
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Trutnov, Česko, 541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
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Třinec, Česko, 739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
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Athens, Řecko, 11527
- "Laiko" General Hospital of Athens
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Athens, Řecko, 10676
- Evangelismos Hospital
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Athens, Řecko, GR-11521
- Naval Hospital of Athens
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Athens, Řecko, 11527
- 'G. Gennimatas' General Hospital of Athens
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Athens, Řecko, 14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
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Athens, Řecko, 15123
- "Hygeia" General Hospital of Athens
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Athens, Řecko, 11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
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Athens, Řecko, 15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
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Athens, Řecko, 11521
- Naval Hospital of Athens - Clinic of Cardiology
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Chaidari, Athens, Řecko, GR-12462
- U.G.H of Athens "Attikon"
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Chaidari, Athens, Řecko, 12462
- U.G.H of Athens "Attikon"
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Chalcis, Řecko, 34100
- General Hospital of Kalamata - Cardiology Department
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Chios, Řecko, 82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
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Larissa, Řecko, 41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
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Marousi, Řecko, 151 26
- Sismanogleio General Hospital - Cardiology Department
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Thessaloniki, Řecko, 54636
- "AHEPA" University General Hospital of Thessaloniki
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Thessaloniki, Řecko, 54642
- 'Ippokrateio' General Hospital of Thessaloniki
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Thessaloniki, Řecko, 57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
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Attica
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Athens, Attica, Řecko, 11528
- Alexandra General Hospital, Therapeutic Clinic
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Madrid, Španělsko, 28007
- Hospital Gregorio Marañón
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Madrid, Španělsko, 28034
- Hospital Ramón y Cajal
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Sanlúcar de Barrameda, Španělsko, 11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
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Santiago de Compostela, Španělsko, 15706
- Complejo Hospitalario Universitario de Santiago
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Seville, Španělsko, 41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
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Valencia, Španělsko, 46010
- Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
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Andalusia
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Castilleja de la Cuesta, Andalusia, Španělsko, 41950
- Hospital Vithas Sevilla
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Castille and León
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Salamanca, Castille and León, Španělsko, 37007
- Hospital Universitario de Salamanca
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Madrid
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Majadahonda, Madrid, Španělsko, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
-
Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
-
Disease specific - cardiovascular:
-
N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
-
Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
-
Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
-
Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
- Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m^2)
- LA diameter greater than or equal to 3.8 centimeters (cm)
- LA length greater than or equal to 5.0 cm
- LA area greater than or equal to 20 square centimeters (cm^2)
- LA volume greater than or equal to 55 milliliters (mL)
- Intraventricular septal thickness greater than or equal to 1.1 cm
- Posterior wall thickness greater than or equal to 1.1 cm
- LV mass index greater than or equal to 115 grams per square meter (g/m^2) in men or greater than or equal to 95 g/m^2 in women
h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeters per second (cm/s)
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No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
-
Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
-
Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening
Exclusion Criteria:
- Medical conditions - cardiovascular:
- Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
- Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
- Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
- Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
- Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
- Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
- Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
- Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
- Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
- Medical conditions - infections/immunosuppression:
- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: Ziltivekimab
Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months. |
Zilitivekimab will be administered subcutaneously once-monthly. |
|
Komparátor placeba: Placebo
Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months. |
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants improving 5 points or more in KCCQ-CSS (yes/no)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants improving 10 points or more in KCCQ-CSS (yes/no)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in six-minute walk distance (6MWD)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured in meters. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in high-sensitivity C-reactive protein (hs-CRP)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
|
|
Change in eGFR (CKD-EPI)
Časové okno: From randomisation (month 0) to end-of-treatment (month 12)
|
eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73^2). |
From randomisation (month 0) to end-of-treatment (month 12)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Clinical Transparency dept. 2834, Novo Nordisk A/S
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
1. dubna 2024
Primární dokončení (Odhadovaný)
Primární dokončení
1. října 2026
Dokončení studie (Odhadovaný)
Dokončení studie
8. ledna 2027
Termíny zápisu do studia
První předloženo
První předloženo
28. prosince 2023
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
28. prosince 2023
První zveřejněno (Aktuální)
První zveřejněno
10. ledna 2024
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
1. října 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
30. září 2026
Naposledy ověřeno
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- NN6018-4914
- U1111-1293-7516 (Jiný identifikátor: World Health Organisation (WHO))
- 2023-506988-34 (Jiný identifikátor: European Medical Agency (EMA))
- 2023 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .