Исследование, изучающее, как работает Зилтивекимаб по сравнению с плацебо у участников с сердечной недостаточностью и воспалением (ATHENA)
Влияние Зилтивекимаба по сравнению с плацебо на симптомы сердечной недостаточности и физическую функцию у пациентов с сердечной недостаточностью с незначительно сниженной или сохраненной фракцией выброса и системным воспалением
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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, Австралия, 2605
- Canberra Hospital
-
-
New South Wales
-
New Lambton Heights, New South Wales, Австралия, 2305
- John Hunter Hospital
-
New Lambton Heights, New South Wales, Австралия, 2305
- John Hunter Hospital - Cardiovascular Department
-
Wollongong, New South Wales, Австралия, 2500
- Illawarra Heart Health Centre
-
-
Queensland
-
Brisbane, Queensland, Австралия, 4032
- The Prince Charles Hospital
-
Chermside, Queensland, Австралия, 4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
-
-
Victoria
-
Ballarat, Victoria, Австралия, 3350
- Ballarat Base Hospital
-
Epping, Victoria, Австралия, 3076
- The Cardiologists Pty Ltd
-
Epping, Victoria, Австралия, 3076
- Northern Private Hospital Epping - The Cardiologists
-
Mulgrave, Victoria, Австралия, 3170
- Advara HeartCare Mulgrave
-
Mulgrave, Victoria, Австралия, 3170
- Advara HeartCare
-
-
Western Australia
-
Murdoch, Western Australia, Австралия, 6150
- Fiona Stanley Hospital Cardiology
-
-
-
-
-
Buenos Aires, Аргентина, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
-
Buenos Aires, Аргентина, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
-
Buenos Aires, Аргентина, C1119ACN
- CIPREC Pueyrredon
-
CABA, Аргентина, C1061AAS
- CIPREC Arenales
-
Esperanza, Santa Fe, Аргентина, S3080BQV
- Sanatorio Esperanza
-
Morón, Аргентина, B1708IFF
- Consultorio Integral de Atención al Diabético
-
Salta, Аргентина, 4400
- Centro Cardiovascular Salta
-
San Miguel de Tucumán, Tucumán., Аргентина, T4000
- Investigaciones Clinicas Tucuman
-
-
Buenos Aires
-
City of Buenos Aires, Buenos Aires, Аргентина, C1425
- Cardiología Palermo
-
Lanús Este, Buenos Aires, Аргентина, B1824KAJ
- Centro Médico CIMEL
-
-
-
-
-
Blagoevgrad, Болгария, 2700
- MHAT Puls AD, Cardiology Department
-
Haskovo, Болгария, 6300
- MHAT Haskovo AD
-
Pleven, Болгария, 5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
-
Plovdiv, Болгария, 4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
-
Sofia, Болгария, 1784
- Medical Center Synexus Sofia EOOD
-
Sofia, Болгария, 1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
-
Sofia, Болгария, 1510
- MC Hera EOOD - Sofia
-
Sofia, Болгария, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
-
Sofia, Болгария, 1606
- UMHATEM N.I. Pirogov EAD
-
-
-
-
-
Bremen, Германия, 28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
-
Dresden, Германия, 01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
-
Elsterwerda, Германия, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
-
Erfurt, Германия, 99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
-
Frankfurt, Германия, 60389
- MVZ CCB Frankfurt und Main-Taunus GbR
-
Freiburg im Breisgau, Германия, 79106
- Universitätsklinikum Freiburg - Medical Center
-
Fulda, Германия, 36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
-
Homburg, Германия, 66421
- Universität des Saarlandes - Innere Med. III
-
Kaiserslautern, Германия, 67655
- Kardiopraxis Schirmer
-
Mainz, Германия, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
-
-
-
-
-
Athens, Греция, 11527
- "Laiko" General Hospital of Athens
-
Athens, Греция, 10676
- Evangelismos Hospital
-
Athens, Греция, GR-11521
- Naval Hospital of Athens
-
Athens, Греция, 11527
- 'G. Gennimatas' General Hospital of Athens
-
Athens, Греция, 14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
-
Athens, Греция, 15123
- "Hygeia" General Hospital of Athens
-
Athens, Греция, 11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
-
Athens, Греция, 15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
-
Athens, Греция, 11521
- Naval Hospital of Athens - Clinic of Cardiology
-
Chaidari, Athens, Греция, GR-12462
- U.G.H of Athens "Attikon"
-
Chaidari, Athens, Греция, 12462
- U.G.H of Athens "Attikon"
-
Chalcis, Греция, 34100
- General Hospital of Kalamata - Cardiology Department
-
Chios, Греция, 82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
-
Larissa, Греция, 41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
-
Marousi, Греция, 151 26
- Sismanogleio General Hospital - Cardiology Department
-
Thessaloniki, Греция, 54636
- "AHEPA" University General Hospital of Thessaloniki
-
Thessaloniki, Греция, 54642
- 'Ippokrateio' General Hospital of Thessaloniki
-
Thessaloniki, Греция, 57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
-
-
Attica
-
Athens, Attica, Греция, 11528
- Alexandra General Hospital, Therapeutic Clinic
-
-
-
-
Andhra Pradesh
-
Vijayawada, Andhra Pradesh, Индия, 520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
-
Visakhapatnam, Andhra Pradesh, Индия, 530002
- King George Hospital
-
-
Gujarat
-
Vadodara, Gujarat, Индия, 390022
- Rhythm Heart Institute
-
-
Karnataka
-
Belagavi, Karnataka, Индия, 590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Belagavi, Karnataka, Индия, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Bengaluru, Karnataka, Индия, 560034
- St John's Medical College Hospital
-
Bengaluru, Karnataka, Индия, 560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
-
Mysuru, Karnataka, Индия, 570015
- Manipal Hospital, Mysuru
-
Udupi, Karnataka, Индия, 576104
- Kasturba Medical College and Hospital, Manipal
-
-
Maharashtra
-
Nagpur, Maharashtra, Индия, 441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
-
Nagpur, Maharashtra, Индия, 440033
- Sengupta Hospital and Research Institute
-
Nashik, Maharashtra, Индия, 422005
- Vijan Hospital & Research Centre
-
Nashik, Maharashtra, Индия, 422005
- Chopda Medicare and Research Centre Pvt. Ltd.
-
Pune, Maharashtra, Индия, 411028
- Villoo Poonawalla Memorial Hospital
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Индия, 110029
- All India Institute of Medical Sciences (AIIMS)
-
New Delhi, National Capital Territory of Delhi, Индия, 110060
- Sir Ganga Ram Hospital
-
New Delhi, National Capital Territory of Delhi, Индия, 110002
- G B Pant Institute of Postgraduate Medical Education and Research
-
New Delhi, National Capital Territory of Delhi, Индия, 110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
-
New Delhi, National Capital Territory of Delhi, Индия, 110093
- Rajiv Gandhi Super Speciality Hospital
-
-
Odisha
-
Bhubaneswar, Odisha, Индия, 751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
-
-
Rajasthan
-
Bikaner, Rajasthan, Индия, 334003
- S.P. Medical College & Associated Group of Hospitals
-
-
Tamil Nadu
-
Puducherry, Tamil Nadu, Индия, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
-
-
Telangana
-
Hyderabad, Telangana, Индия, 500020
- Guru Nanak CARE Hospitals
-
Hyderabad, Telangana, Индия, 500055
- Malla Reddy Narayana Multispeciality Hospital
-
-
Uttar Pradesh
-
Aligarh, Uttar Pradesh, Индия, 202002
- Jawaharlal Nehru Medical College and Hospital
-
Kanpur, Uttar Pradesh, Индия, 208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
-
Lucknow, Uttar Pradesh, Индия, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
-
Lucknow, Uttar Pradesh, Индия, 226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
-
-
Utter Pradesh
-
Aligarh, Utter Pradesh, Индия, 202002
- Jawaharlal Nehru Medical College and Hospital
-
-
West Bengal
-
Kolkata, West Bengal, Индия, 700027
- B M Birla Heart Research Centre
-
-
-
-
-
Madrid, Испания, 28007
- Hospital Gregorio Marañón
-
Madrid, Испания, 28034
- Hospital Ramón y Cajal
-
Sanlúcar de Barrameda, Испания, 11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
-
Santiago de Compostela, Испания, 15706
- Complejo Hospitalario Universitario de Santiago
-
Seville, Испания, 41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
-
Valencia, Испания, 46010
- Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
-
-
Andalusia
-
Castilleja de la Cuesta, Andalusia, Испания, 41950
- Hospital Vithas Sevilla
-
-
Castille and León
-
Salamanca, Castille and León, Испания, 37007
- Hospital Universitario de Salamanca
-
-
Madrid
-
Majadahonda, Madrid, Испания, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
-
-
-
Québec, Канада, G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
-
-
Alberta
-
Calgary, Alberta, Канада, T2N 4Z6
- University of Calgary_Calgary
-
-
Ontario
-
Cambridge, Ontario, Канада, N1R 6V6
- Cambridge Cardiac Care Centre
-
Cambridge, Ontario, Канада, N1R 7R1
- Saul Vizel Pro. Med. Corp
-
Scarborough Village, Ontario, Канада, M1B 5N1
- Corcare Cardiovascular Research
-
Toronto, Ontario, Канада, M6G 1M2
- Diabetes Heart Research Centre
-
Waterloo, Ontario, Канада, N2T 0C1
- CPS Research
-
Waterloo, Ontario, Канада, N2T OC1
- Clinical Research Solutions Inc.
-
-
Quebec
-
Montreal, Quebec, Канада, H1T 1C8
- Institut de Cardiologie de Montreal
-
Montreal, Quebec, Канада, H3G 1A4
- Montreal General Hospital
-
-
-
-
-
Kota Bharu, Kelantan, Малайзия, 15586
- Hospital Raja Perempuan Zainab II
-
-
Johor
-
Johor Bahru, Johor, Малайзия, 80100
- Hospital Sultanah Aminah
-
-
Kedah
-
Alor Star, Kedah, Малайзия, 05460
- Hospital Sultanah Bahiyah
-
-
Kelantan
-
Kota Bharu, Kelantan, Малайзия, 15586
- Hospital Raja Perempuan Zainab II
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Малайзия, 59100
- University Malaya Medical Centre
-
Lembah Pantai, Kuala Lumpur, Малайзия, 59100
- University Malaya Medical Centre
-
-
Pahang
-
Kuantan, Pahang, Малайзия, 25100
- Hospital Tengku Ampuan Afzan
-
-
Perak
-
Ipoh, Perak, Малайзия, 30450
- Hospital Raja Permaisuri Bainun Ipoh
-
-
Selangor
-
Kajang, Selangor, Малайзия, 43000
- Hospital Serdang
-
-
-
-
-
Bielsko-Biala, Польша, 43-316
- American Heart of Poland S.A.
-
Bydgoszcz, Польша, 85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
-
Gdynia, Польша, 81-348
- Szpitale Pomorskie Sp. z o.o.
-
Lublin, Польша, 20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Piotrkow Trybunalski, Польша, 97-300
- Trialmed Sp. z o. o.
-
Poznan, Польша, 61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
-
Tychy, Польша, 43-100
- American Heart of Poland S.A.
-
Warsaw, Польша, 02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Польша, 85-605
- Centrum Medyczne Intercor Sp. z o.o.
-
Włocławek, Kuyavian-Pomeranian Voivodeship, Польша, 87-800
- Kardio Life
-
Włocławek, Kuyavian-Pomeranian Voivodeship, Польша, 87-800
- Kardio Life - Tomasz Borkowski
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Польша, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Lesser Poland Voivodeship, Польша, 30-002
- Cardiomedicum Sp. z o.o.
-
Oświęcim, Lesser Poland Voivodeship, Польша, 32-600
- Formed 2 Sp. z o.o.
-
-
Lower Silesian Voivodeship
-
Jelenia Góra, Lower Silesian Voivodeship, Польша, 58-506
- Pratia S.A.
-
Wroclaw, Lower Silesian Voivodeship, Польша, 50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
-
-
Lublin Voivodeship
-
Puławy, Lublin Voivodeship, Польша, 24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
-
-
Masovian Voivodeship
-
Żyrardów, Masovian Voivodeship, Польша, 96-300
- Prywatna Praktyka Lekarska Anna Chudoba
-
-
Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, Польша, 15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
-
Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Польша, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
Gdynia, Pomeranian Voivodeship, Польша, 81-348
- Szpitale Pomorskie Sp. z o.o.
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Польша, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Lodz, Łódź Voivodeship, Польша, 90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
-
-
-
-
-
Guilhufe - Penafiel, Португалия, 4560-136
- CHTâmega e Sousa - Hospital Padre Américo
-
Lisbon, Португалия, 1500-650
- Hospital da Luz
-
Lisbon, Португалия, 1649-035
- Centro Hospitalar Lisboa Norte
-
Lisbon, Португалия, 1449-005
- CHLO, EPE - Hospital São Francisco Xavier
-
Setúbal, Португалия, 2910-446
- Centro Hospitalar de Setubal
-
-
-
-
-
Birmingham, Соединенное Королевство, B21 9RY
- FutureMeds
-
Dundee, Соединенное Королевство, DD2 1GZ
- Ninewells Hospital
-
Peterborough, Соединенное Королевство, PE3 9GZ
- Peterborough City Hospital
-
-
Highland
-
Inverness, Highland, Соединенное Королевство, IV2 3JH
- Raigmore Hospital
-
-
West Sussex
-
Chichester, West Sussex, Соединенное Королевство, PO19 6SE
- St. Richard's Hospital_Cardiology
-
-
-
-
Alabama
-
Alexander City, Alabama, Соединенные Штаты, 35010
- Advanced Cardiovascular, LLC
-
Fairhope, Alabama, Соединенные Штаты, 36532
- Eastern Shore Rsrch Inst, LLC
-
-
Arkansas
-
Little Rock, Arkansas, Соединенные Штаты, 72204
- Cardiology & Medicine Clinic
-
-
California
-
Northridge, California, Соединенные Штаты, 91325
- Valley Clinical Trials, Inc.
-
Orange, California, Соединенные Штаты, 92868
- UCI Health
-
Pasadena, California, Соединенные Штаты, 91105
- South California Heart Spc
-
-
Florida
-
Largo, Florida, Соединенные Штаты, 33777
- Clearwater Cardiovascular Consultants
-
Ocala, Florida, Соединенные Штаты, 34471
- Ocala Cardiovascular Research
-
Ormond Beach, Florida, Соединенные Штаты, 32174
- Ormond Beach Clinical Research
-
Saint Augustine, Florida, Соединенные Штаты, 32086
- St Johns Ctr Clin Rsch-St. Aug
-
-
Georgia
-
Macon, Georgia, Соединенные Штаты, 31201
- GA Arrhythmia Cons & Rsch Inst
-
Savannah, Georgia, Соединенные Штаты, 31406
- Velocity Clin Rsrch - Savannah
-
-
Illinois
-
Hazel Crest, Illinois, Соединенные Штаты, 60429
- Chicago Medical Research LLC
-
-
Kentucky
-
Louisville, Kentucky, Соединенные Штаты, 40202
- UofL Health Care Outpatient
-
-
Maryland
-
Baltimore, Maryland, Соединенные Штаты, 21229
- Maryland Cardiovascular Specialists - Baltimore
-
Oxon Hill, Maryland, Соединенные Штаты, 20745
- MD Medical Research
-
-
Michigan
-
Bloomfield Hills, Michigan, Соединенные Штаты, 48304
- Cardio and Vascular Assoc-CAVA
-
Farmington Hills, Michigan, Соединенные Штаты, 48334
- Millennium Cardiology
-
-
Missouri
-
Kansas City, Missouri, Соединенные Штаты, 64128
- Kansas City VA Medical Center
-
St Louis, Missouri, Соединенные Штаты, 63110
- Washington University
-
-
Nevada
-
Reno, Nevada, Соединенные Штаты, 89502
- Renown Regional Medical Center
-
-
New York
-
Lake Success, New York, Соединенные Штаты, 11042
- Long Island Cardiovascular Consultants PC
-
New York, New York, Соединенные Штаты, 10019
- Mount Sinai Hosp at NYC
-
Riverhead, New York, Соединенные Штаты, 11901
- Northwell Health Phys Cardio
-
-
North Carolina
-
Chapel Hill, North Carolina, Соединенные Штаты, 27599-7046
- University Of North Carolina At Chapel Hill
-
-
Pennsylvania
-
Horsham, Pennsylvania, Соединенные Штаты, 19044
- AMS Cardiology
-
Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- Univ of Pennsylvania Hospital
-
-
Texas
-
Amarillo, Texas, Соединенные Штаты, 79106
- PharmaTex Research
-
Dallas, Texas, Соединенные Штаты, 75390-9302
- University of Texas Southwestern Medical Center
-
El Paso, Texas, Соединенные Штаты, 79905
- David Turbay, MD, PLLC
-
Katy, Texas, Соединенные Штаты, 77493
- Private Practice Leadership LLC.
-
San Antonio, Texas, Соединенные Штаты, 78212
- Clinical Advancement Center
-
San Antonio, Texas, Соединенные Штаты, 78212
- Clinical Advancement Ctr, PLLC
-
Sherman, Texas, Соединенные Штаты, 75090
- Sherman Clinical Research
-
Tomball, Texas, Соединенные Штаты, 77375
- Northwest Heart Center
-
-
Virginia
-
Norfolk, Virginia, Соединенные Штаты, 23507
- Sentara Health Research Center
-
Richmond, Virginia, Соединенные Штаты, 23219
- Virginia Commonwealth University
-
-
-
-
-
Adana, Турция (Туркие), 01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
-
Adana, Турция (Туркие), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Afyonkarahisar, Турция (Туркие), 03200
- Afyonkarahisar Health Sciences University
-
Afyonkarahisar, Турция (Туркие), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
-
Ankara, Турция (Туркие), 06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
-
Ankara, Турция (Туркие), 06800
- Ankara Sehir Hastanesi Cardiology
-
Bursa, Турция (Туркие), 16110
- Bursa Şehir Hastanesi- Kardiyoloji
-
Edirne, Турция (Туркие), 22030
- Trakya University
-
Edirne, Турция (Туркие), 22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
-
Istanbul, Турция (Туркие), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
-
Kayseri, Турция (Туркие), 38039
- Erciyes University Cardiology
-
Kayseri, Турция (Туркие), 38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
-
Kocaeli, Турция (Туркие), 41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
-
-
Odunpazari
-
Eskişehir, Odunpazari, Турция (Туркие), 26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
-
-
-
-
-
Chambray-lès-Tours, Франция, 37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
-
Poitiers, Франция, 86000
- Centre Hospitalier Universitaire de Poitiers
-
Rennes, Франция, 35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, Франция, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
-
Toulon, Франция, 83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
-
Valenciennes, Франция, 59300
- Polyclinique Vauban
-
Vandœuvre-lès-Nancy, Франция, 54500
- Chru de Nancy - Hopital Brabois
-
-
-
-
-
Benešov, Чехия, 256 01
- Innera s.r.o.
-
Brno, Чехия, 612 00
- Kardiologicka ambulance Brno s.r.o.
-
Brno, Чехия, 61500
- Vojenská nemocnice Brno p.o.
-
Chomutov, Чехия, 430 02
- Ordinace pro choroby srdce
-
Prague, Чехия, 170 00
- MEDICON a.s.
-
Svitavy, Чехия, 568 25
- Svitavska nemocnice Kardiologie
-
Trutnov, Чехия, 541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
-
Třinec, Чехия, 739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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)
-
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: 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. |
|
Плацебо Компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Clinical Transparency dept. 2834, Novo Nordisk A/S
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- NN6018-4914
- U1111-1293-7516 (Другой идентификатор: World Health Organisation (WHO))
- 2023-506988-34 (Другой идентификатор: European Medical Agency (EMA))
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .