心不全および炎症を患う参加者においてジルチベキマブがプラセボと比較してどのように作用するかを調査した研究研究 (ATHENA)
駆出率が軽度に低下または維持され、全身性炎症を伴う心不全患者における心不全の症状および身体機能に対するジルチベキマブとプラセボの効果
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
-
Alexander City、Alabama、アメリカ、35010
- Advanced Cardiovascular, LLC
-
Fairhope、Alabama、アメリカ、36532
- Eastern Shore Rsrch Inst, LLC
-
-
Arkansas
-
Little Rock、Arkansas、アメリカ、72204
- Cardiology & Medicine Clinic
-
-
California
-
Northridge、California、アメリカ、91325
- Valley Clinical Trials, Inc.
-
Orange、California、アメリカ、92868
- UCI Health
-
Pasadena、California、アメリカ、91105
- South California Heart Spc
-
-
Florida
-
Largo、Florida、アメリカ、33777
- Clearwater Cardiovascular Consultants
-
Ocala、Florida、アメリカ、34471
- Ocala Cardiovascular Research
-
Ormond Beach、Florida、アメリカ、32174
- Ormond Beach Clinical Research
-
Saint Augustine、Florida、アメリカ、32086
- St Johns Ctr Clin Rsch-St. Aug
-
-
Georgia
-
Macon、Georgia、アメリカ、31201
- GA Arrhythmia Cons & Rsch Inst
-
Savannah、Georgia、アメリカ、31406
- Velocity Clin Rsrch - Savannah
-
-
Illinois
-
Hazel Crest、Illinois、アメリカ、60429
- Chicago Medical Research LLC
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40202
- UofL Health Care Outpatient
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21229
- Maryland Cardiovascular Specialists - Baltimore
-
Oxon Hill、Maryland、アメリカ、20745
- MD Medical Research
-
-
Michigan
-
Bloomfield Hills、Michigan、アメリカ、48304
- Cardio and Vascular Assoc-CAVA
-
Farmington Hills、Michigan、アメリカ、48334
- Millennium Cardiology
-
-
Missouri
-
Kansas City、Missouri、アメリカ、64128
- Kansas City VA Medical Center
-
St Louis、Missouri、アメリカ、63110
- Washington University
-
-
Nevada
-
Reno、Nevada、アメリカ、89502
- Renown Regional Medical Center
-
-
New York
-
Lake Success、New York、アメリカ、11042
- Long Island Cardiovascular Consultants PC
-
New York、New York、アメリカ、10019
- Mount Sinai Hosp at NYC
-
Riverhead、New York、アメリカ、11901
- Northwell Health Phys Cardio
-
-
North Carolina
-
Chapel Hill、North Carolina、アメリカ、27599-7046
- University Of North Carolina At Chapel Hill
-
-
Pennsylvania
-
Horsham、Pennsylvania、アメリカ、19044
- AMS Cardiology
-
Philadelphia、Pennsylvania、アメリカ、19104
- Univ of Pennsylvania Hospital
-
-
Texas
-
Amarillo、Texas、アメリカ、79106
- PharmaTex Research
-
Dallas、Texas、アメリカ、75390-9302
- University of Texas Southwestern Medical Center
-
El Paso、Texas、アメリカ、79905
- David Turbay, MD, PLLC
-
Katy、Texas、アメリカ、77493
- Private Practice Leadership LLC.
-
San Antonio、Texas、アメリカ、78212
- Clinical Advancement Center
-
San Antonio、Texas、アメリカ、78212
- Clinical Advancement Ctr, PLLC
-
Sherman、Texas、アメリカ、75090
- Sherman Clinical Research
-
Tomball、Texas、アメリカ、77375
- Northwest Heart Center
-
-
Virginia
-
Norfolk、Virginia、アメリカ、23507
- Sentara Health Research Center
-
Richmond、Virginia、アメリカ、23219
- Virginia Commonwealth University
-
-
-
-
-
Buenos Aires、アルゼンチン、C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
-
Buenos Aires、アルゼンチン、B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
-
Buenos Aires、アルゼンチン、C1119ACN
- CIPREC Pueyrredon
-
CABA、アルゼンチン、C1061AAS
- CIPREC Arenales
-
Esperanza, Santa Fe、アルゼンチン、S3080BQV
- Sanatorio Esperanza
-
Morón、アルゼンチン、B1708IFF
- Consultorio Integral de Atención al Diabético
-
Salta、アルゼンチン、4400
- Centro Cardiovascular Salta
-
San Miguel de Tucumán, Tucumán.、アルゼンチン、T4000
- Investigaciones Clinicas Tucuman
-
-
Buenos Aires
-
City of Buenos Aires、Buenos Aires、アルゼンチン、C1425
- Cardiología Palermo
-
Lanús Este、Buenos Aires、アルゼンチン、B1824KAJ
- Centro Médico CIMEL
-
-
-
-
-
Birmingham、イギリス、B21 9RY
- FutureMeds
-
Dundee、イギリス、DD2 1GZ
- Ninewells Hospital
-
Peterborough、イギリス、PE3 9GZ
- Peterborough City Hospital
-
-
Highland
-
Inverness、Highland、イギリス、IV2 3JH
- Raigmore Hospital
-
-
West Sussex
-
Chichester、West Sussex、イギリス、PO19 6SE
- St. Richard's Hospital_Cardiology
-
-
-
-
Andhra Pradesh
-
Vijayawada、Andhra Pradesh、インド、520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
-
Visakhapatnam、Andhra Pradesh、インド、530002
- King George Hospital
-
-
Gujarat
-
Vadodara、Gujarat、インド、390022
- Rhythm Heart Institute
-
-
Karnataka
-
Belagavi、Karnataka、インド、590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Belagavi、Karnataka、インド、590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
-
Bengaluru、Karnataka、インド、560034
- St John's Medical College Hospital
-
Bengaluru、Karnataka、インド、560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
-
Mysuru、Karnataka、インド、570015
- Manipal Hospital, Mysuru
-
Udupi、Karnataka、インド、576104
- Kasturba Medical College and Hospital, Manipal
-
-
Maharashtra
-
Nagpur、Maharashtra、インド、441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
-
Nagpur、Maharashtra、インド、440033
- Sengupta Hospital and Research Institute
-
Nashik、Maharashtra、インド、422005
- Vijan Hospital & Research Centre
-
Nashik、Maharashtra、インド、422005
- Chopda Medicare and Research Centre Pvt. Ltd.
-
Pune、Maharashtra、インド、411028
- Villoo Poonawalla Memorial Hospital
-
-
National Capital Territory of Delhi
-
New Delhi、National Capital Territory of Delhi、インド、110029
- All India Institute of Medical Sciences (AIIMS)
-
New Delhi、National Capital Territory of Delhi、インド、110060
- Sir Ganga Ram Hospital
-
New Delhi、National Capital Territory of Delhi、インド、110002
- G B Pant Institute of Postgraduate Medical Education and Research
-
New Delhi、National Capital Territory of Delhi、インド、110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
-
New Delhi、National Capital Territory of Delhi、インド、110093
- Rajiv Gandhi Super Speciality Hospital
-
-
Odisha
-
Bhubaneswar、Odisha、インド、751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
-
-
Rajasthan
-
Bikaner、Rajasthan、インド、334003
- S.P. Medical College & Associated Group of Hospitals
-
-
Tamil Nadu
-
Puducherry、Tamil Nadu、インド、605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
-
-
Telangana
-
Hyderabad、Telangana、インド、500020
- Guru Nanak CARE Hospitals
-
Hyderabad、Telangana、インド、500055
- Malla Reddy Narayana Multispeciality Hospital
-
-
Uttar Pradesh
-
Aligarh、Uttar Pradesh、インド、202002
- Jawaharlal Nehru Medical College and Hospital
-
Kanpur、Uttar Pradesh、インド、208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
-
Lucknow、Uttar Pradesh、インド、226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
-
Lucknow、Uttar Pradesh、インド、226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
-
-
Utter Pradesh
-
Aligarh、Utter Pradesh、インド、202002
- Jawaharlal Nehru Medical College and Hospital
-
-
West Bengal
-
Kolkata、West Bengal、インド、700027
- B M Birla Heart Research Centre
-
-
-
-
Australian Capital Territory
-
Garran、Australian Capital Territory、オーストラリア、2605
- Canberra Hospital
-
-
New South Wales
-
New Lambton Heights、New South Wales、オーストラリア、2305
- John Hunter Hospital
-
New Lambton Heights、New South Wales、オーストラリア、2305
- John Hunter Hospital - Cardiovascular Department
-
Wollongong、New South Wales、オーストラリア、2500
- Illawarra Heart Health Centre
-
-
Queensland
-
Brisbane、Queensland、オーストラリア、4032
- The Prince Charles Hospital
-
Chermside、Queensland、オーストラリア、4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
-
-
Victoria
-
Ballarat、Victoria、オーストラリア、3350
- Ballarat Base Hospital
-
Epping、Victoria、オーストラリア、3076
- The Cardiologists Pty Ltd
-
Epping、Victoria、オーストラリア、3076
- Northern Private Hospital Epping - The Cardiologists
-
Mulgrave、Victoria、オーストラリア、3170
- Advara HeartCare Mulgrave
-
Mulgrave、Victoria、オーストラリア、3170
- Advara HeartCare
-
-
Western Australia
-
Murdoch、Western Australia、オーストラリア、6150
- Fiona Stanley Hospital Cardiology
-
-
-
-
-
Québec、カナダ、G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
-
-
Alberta
-
Calgary、Alberta、カナダ、T2N 4Z6
- University of Calgary_Calgary
-
-
Ontario
-
Cambridge、Ontario、カナダ、N1R 6V6
- Cambridge Cardiac Care Centre
-
Cambridge、Ontario、カナダ、N1R 7R1
- Saul Vizel Pro. Med. Corp
-
Scarborough Village、Ontario、カナダ、M1B 5N1
- Corcare Cardiovascular Research
-
Toronto、Ontario、カナダ、M6G 1M2
- Diabetes Heart Research Centre
-
Waterloo、Ontario、カナダ、N2T 0C1
- CPS Research
-
Waterloo、Ontario、カナダ、N2T OC1
- Clinical Research Solutions Inc.
-
-
Quebec
-
Montreal、Quebec、カナダ、H1T 1C8
- Institut de Cardiologie de Montreal
-
Montreal、Quebec、カナダ、H3G 1A4
- Montreal General Hospital
-
-
-
-
-
Athens、ギリシャ、11527
- "Laiko" General Hospital of Athens
-
Athens、ギリシャ、10676
- Evangelismos Hospital
-
Athens、ギリシャ、GR-11521
- Naval Hospital of Athens
-
Athens、ギリシャ、11527
- 'G. Gennimatas' General Hospital of Athens
-
Athens、ギリシャ、14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
-
Athens、ギリシャ、15123
- "Hygeia" General Hospital of Athens
-
Athens、ギリシャ、11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
-
Athens、ギリシャ、15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
-
Athens、ギリシャ、11521
- Naval Hospital of Athens - Clinic of Cardiology
-
Chaidari, Athens、ギリシャ、GR-12462
- U.G.H of Athens "Attikon"
-
Chaidari, Athens、ギリシャ、12462
- U.G.H of Athens "Attikon"
-
Chalcis、ギリシャ、34100
- General Hospital of Kalamata - Cardiology Department
-
Chios、ギリシャ、82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
-
Larissa、ギリシャ、41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
-
Marousi、ギリシャ、151 26
- Sismanogleio General Hospital - Cardiology Department
-
Thessaloniki、ギリシャ、54636
- "AHEPA" University General Hospital of Thessaloniki
-
Thessaloniki、ギリシャ、54642
- 'Ippokrateio' General Hospital of Thessaloniki
-
Thessaloniki、ギリシャ、57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
-
-
Attica
-
Athens、Attica、ギリシャ、11528
- Alexandra General Hospital, Therapeutic Clinic
-
-
-
-
-
Madrid、スペイン、28007
- Hospital Gregorio Marañón
-
Madrid、スペイン、28034
- Hospital Ramón y Cajal
-
Sanlúcar de Barrameda、スペイン、11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
-
Santiago de Compostela、スペイン、15706
- Complejo Hospitalario Universitario de Santiago
-
Seville、スペイン、41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
-
Valencia、スペイン、46010
- Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
-
-
Andalusia
-
Castilleja de la Cuesta、Andalusia、スペイン、41950
- Hospital Vithas Sevilla
-
-
Castille and León
-
Salamanca、Castille and León、スペイン、37007
- Hospital Universitario de Salamanca
-
-
Madrid
-
Majadahonda、Madrid、スペイン、28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
-
-
-
Benešov、チェコ、256 01
- Innera s.r.o.
-
Brno、チェコ、612 00
- Kardiologicka ambulance Brno s.r.o.
-
Brno、チェコ、61500
- Vojenská nemocnice Brno p.o.
-
Chomutov、チェコ、430 02
- Ordinace pro choroby srdce
-
Prague、チェコ、170 00
- MEDICON a.s.
-
Svitavy、チェコ、568 25
- Svitavska nemocnice Kardiologie
-
Trutnov、チェコ、541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
-
Třinec、チェコ、739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
-
-
-
-
-
Adana、トルコ（Türkiye）、01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
-
Adana、トルコ（Türkiye）、01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Afyonkarahisar、トルコ（Türkiye）、03200
- Afyonkarahisar Health Sciences University
-
Afyonkarahisar、トルコ（Türkiye）、03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
-
Ankara、トルコ（Türkiye）、06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
-
Ankara、トルコ（Türkiye）、06800
- Ankara Sehir Hastanesi Cardiology
-
Bursa、トルコ（Türkiye）、16110
- Bursa Şehir Hastanesi- Kardiyoloji
-
Edirne、トルコ（Türkiye）、22030
- Trakya University
-
Edirne、トルコ（Türkiye）、22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
-
Istanbul、トルコ（Türkiye）、34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
-
Kayseri、トルコ（Türkiye）、38039
- Erciyes University Cardiology
-
Kayseri、トルコ（Türkiye）、38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
-
Kocaeli、トルコ（Türkiye）、41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
-
-
Odunpazari
-
Eskişehir、Odunpazari、トルコ（Türkiye）、26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
-
-
-
-
-
Bremen、ドイツ、28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
-
Dresden、ドイツ、01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
-
Elsterwerda、ドイツ、04910
- Zentrum für klinische Studien Südbrandenburg GmbH
-
Erfurt、ドイツ、99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
-
Frankfurt、ドイツ、60389
- MVZ CCB Frankfurt und Main-Taunus GbR
-
Freiburg im Breisgau、ドイツ、79106
- Universitätsklinikum Freiburg - Medical Center
-
Fulda、ドイツ、36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
-
Homburg、ドイツ、66421
- Universität des Saarlandes - Innere Med. III
-
Kaiserslautern、ドイツ、67655
- Kardiopraxis Schirmer
-
Mainz、ドイツ、55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
-
-
-
-
-
Chambray-lès-Tours、フランス、37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
-
Poitiers、フランス、86000
- Centre Hospitalier Universitaire de Poitiers
-
Rennes、フランス、35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen、フランス、76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
-
Toulon、フランス、83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
-
Valenciennes、フランス、59300
- Polyclinique Vauban
-
Vandœuvre-lès-Nancy、フランス、54500
- Chru de Nancy - Hopital Brabois
-
-
-
-
-
Blagoevgrad、ブルガリア、2700
- MHAT Puls AD, Cardiology Department
-
Haskovo、ブルガリア、6300
- MHAT Haskovo AD
-
Pleven、ブルガリア、5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
-
Plovdiv、ブルガリア、4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
-
Sofia、ブルガリア、1784
- Medical Center Synexus Sofia EOOD
-
Sofia、ブルガリア、1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
-
Sofia、ブルガリア、1510
- MC Hera EOOD - Sofia
-
Sofia、ブルガリア、1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
-
Sofia、ブルガリア、1606
- UMHATEM N.I. Pirogov EAD
-
-
-
-
-
Guilhufe - Penafiel、ポルトガル、4560-136
- CHTâmega e Sousa - Hospital Padre Américo
-
Lisbon、ポルトガル、1500-650
- Hospital da Luz
-
Lisbon、ポルトガル、1649-035
- Centro Hospitalar Lisboa Norte
-
Lisbon、ポルトガル、1449-005
- CHLO, EPE - Hospital São Francisco Xavier
-
Setúbal、ポルトガル、2910-446
- Centro Hospitalar de Setubal
-
-
-
-
-
Bielsko-Biala、ポーランド、43-316
- American Heart of Poland S.A.
-
Bydgoszcz、ポーランド、85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
-
Gdynia、ポーランド、81-348
- Szpitale Pomorskie Sp. z o.o.
-
Lublin、ポーランド、20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Piotrkow Trybunalski、ポーランド、97-300
- Trialmed Sp. z o. o.
-
Poznan、ポーランド、61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
-
Tychy、ポーランド、43-100
- American Heart of Poland S.A.
-
Warsaw、ポーランド、02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz、Kuyavian-Pomeranian Voivodeship、ポーランド、85-605
- Centrum Medyczne Intercor Sp. z o.o.
-
Włocławek、Kuyavian-Pomeranian Voivodeship、ポーランド、87-800
- Kardio Life
-
Włocławek、Kuyavian-Pomeranian Voivodeship、ポーランド、87-800
- Kardio Life - Tomasz Borkowski
-
-
Lesser Poland Voivodeship
-
Krakow、Lesser Poland Voivodeship、ポーランド、30-721
- Linden sp. z o.o. sp. k.
-
Krakow、Lesser Poland Voivodeship、ポーランド、30-002
- Cardiomedicum Sp. z o.o.
-
Oświęcim、Lesser Poland Voivodeship、ポーランド、32-600
- Formed 2 Sp. z o.o.
-
-
Lower Silesian Voivodeship
-
Jelenia Góra、Lower Silesian Voivodeship、ポーランド、58-506
- Pratia S.A.
-
Wroclaw、Lower Silesian Voivodeship、ポーランド、50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
-
-
Lublin Voivodeship
-
Puławy、Lublin Voivodeship、ポーランド、24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
-
-
Masovian Voivodeship
-
Żyrardów、Masovian Voivodeship、ポーランド、96-300
- Prywatna Praktyka Lekarska Anna Chudoba
-
-
Podlaskie Voivodeship
-
Bialystok、Podlaskie Voivodeship、ポーランド、15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
-
Pomeranian Voivodeship
-
Gdynia、Pomeranian Voivodeship、ポーランド、81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
Gdynia、Pomeranian Voivodeship、ポーランド、81-348
- Szpitale Pomorskie Sp. z o.o.
-
-
Łódź Voivodeship
-
Lodz、Łódź Voivodeship、ポーランド、93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
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Lodz、Łódź Voivodeship、ポーランド、90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
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Kota Bharu, Kelantan、マレーシア、15586
- Hospital Raja Perempuan Zainab II
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Johor
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Johor Bahru、Johor、マレーシア、80100
- Hospital Sultanah Aminah
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Kedah
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Alor Star、Kedah、マレーシア、05460
- Hospital Sultanah Bahiyah
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Kelantan
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Kota Bharu、Kelantan、マレーシア、15586
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Kuala Lumpur、Kuala Lumpur、マレーシア、59100
- University Malaya Medical Centre
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Lembah Pantai、Kuala Lumpur、マレーシア、59100
- University Malaya Medical Centre
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Pahang
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Kuantan、Pahang、マレーシア、25100
- Hospital Tengku Ampuan Afzan
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Perak
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Ipoh、Perak、マレーシア、30450
- Hospital Raja Permaisuri Bainun Ipoh
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Selangor
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Kajang、Selangor、マレーシア、43000
- Hospital Serdang
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
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Disease specific - cardiovascular:
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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
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Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
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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)
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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
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Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
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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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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アクティブコンパレータ：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. |
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プラセボコンパレーター：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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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)
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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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)
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Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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Measured as count of participants. |
From randomisation (month 0) to end-of-treatment (month 12)
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Participants improving 5 points or more in KCCQ-CSS (yes/no)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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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)
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Participants improving 10 points or more in KCCQ-CSS (yes/no)
時間枠：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)
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Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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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)
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Change in six-minute walk distance (6MWD)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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Measured in meters. |
From randomisation (month 0) to end-of-treatment (month 12)
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Change in high-sensitivity C-reactive protein (hs-CRP)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
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Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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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)
|
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Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
時間枠：From randomisation (month 0) to end-of-treatment (month 12)
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Measured as ratio to baseline. |
From randomisation (month 0) to end-of-treatment (month 12)
|
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Change in eGFR (CKD-EPI)
時間枠：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)
|
協力者と研究者
捜査官
捜査官
- スタディディレクター：Clinical Transparency dept. 2834、Novo Nordisk A/S
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- NN6018-4914
- U1111-1293-7516 (その他の識別子：World Health Organisation (WHO))
- 2023-506988-34 (その他の識別子：European Medical Agency (EMA))
- 2023 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。