심부전 및 염증이 있는 참가자에게 Ziltivekimab이 위약과 비교하여 어떻게 작용하는지 조사하는 연구 조사 (ATHENA)
심박출률과 전신 염증이 약간 감소하거나 보존된 심부전 환자의 심부전 증상 및 신체 기능에 대한 질티베키맙 대 위약의 효과
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Athens, 그리스, 11527
- "Laiko" General Hospital of Athens
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Athens, 그리스, 10676
- Evangelismos Hospital
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Athens, 그리스, GR-11521
- Naval Hospital of Athens
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Athens, 그리스, 11527
- 'G. Gennimatas' General Hospital of Athens
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Athens, 그리스, 14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
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Athens, 그리스, 15123
- "Hygeia" General Hospital of Athens
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Athens, 그리스, 11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
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Athens, 그리스, 15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
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Athens, 그리스, 11521
- Naval Hospital of Athens - Clinic of Cardiology
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Chaidari, Athens, 그리스, GR-12462
- U.G.H of Athens "Attikon"
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Chaidari, Athens, 그리스, 12462
- U.G.H of Athens "Attikon"
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Chalcis, 그리스, 34100
- General Hospital of Kalamata - Cardiology Department
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Chios, 그리스, 82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
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Larissa, 그리스, 41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
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Marousi, 그리스, 151 26
- Sismanogleio General Hospital - Cardiology Department
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Thessaloniki, 그리스, 54636
- "AHEPA" University General Hospital of Thessaloniki
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Thessaloniki, 그리스, 54642
- 'Ippokrateio' General Hospital of Thessaloniki
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Thessaloniki, 그리스, 57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
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Attica
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Athens, Attica, 그리스, 11528
- Alexandra General Hospital, Therapeutic Clinic
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Bremen, 독일, 28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
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Dresden, 독일, 01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
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Elsterwerda, 독일, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Erfurt, 독일, 99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
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Frankfurt, 독일, 60389
- MVZ CCB Frankfurt und Main-Taunus GbR
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Freiburg im Breisgau, 독일, 79106
- Universitätsklinikum Freiburg - Medical Center
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Fulda, 독일, 36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
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Homburg, 독일, 66421
- Universität des Saarlandes - Innere Med. III
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Kaiserslautern, 독일, 67655
- Kardiopraxis Schirmer
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Mainz, 독일, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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-
-
-
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Kota Bharu, Kelantan, 말레이시아, 15586
- Hospital Raja Perempuan Zainab II
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Johor
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Johor Bahru, Johor, 말레이시아, 80100
- Hospital Sultanah Aminah
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Kedah
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Alor Star, Kedah, 말레이시아, 05460
- Hospital Sultanah Bahiyah
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Kelantan
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Kota Bharu, Kelantan, 말레이시아, 15586
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
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Lembah Pantai, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
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Pahang
-
Kuantan, Pahang, 말레이시아, 25100
- Hospital Tengku Ampuan Afzan
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Perak
-
Ipoh, Perak, 말레이시아, 30450
- Hospital Raja Permaisuri Bainun Ipoh
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Selangor
-
Kajang, Selangor, 말레이시아, 43000
- Hospital Serdang
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-
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Alabama
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Alexander City, Alabama, 미국, 35010
- Advanced Cardiovascular, LLC
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Fairhope, Alabama, 미국, 36532
- Eastern Shore Rsrch Inst, LLC
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Arkansas
-
Little Rock, Arkansas, 미국, 72204
- Cardiology & Medicine Clinic
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California
-
Northridge, California, 미국, 91325
- Valley Clinical Trials, Inc.
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Orange, California, 미국, 92868
- UCI Health
-
Pasadena, California, 미국, 91105
- South California Heart Spc
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Florida
-
Largo, Florida, 미국, 33777
- Clearwater Cardiovascular Consultants
-
Ocala, Florida, 미국, 34471
- Ocala Cardiovascular Research
-
Ormond Beach, Florida, 미국, 32174
- Ormond Beach Clinical Research
-
Saint Augustine, Florida, 미국, 32086
- St Johns Ctr Clin Rsch-St. Aug
-
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Georgia
-
Macon, Georgia, 미국, 31201
- GA Arrhythmia Cons & Rsch Inst
-
Savannah, Georgia, 미국, 31406
- Velocity Clin Rsrch - Savannah
-
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Illinois
-
Hazel Crest, Illinois, 미국, 60429
- Chicago Medical Research LLC
-
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Kentucky
-
Louisville, Kentucky, 미국, 40202
- UofL Health Care Outpatient
-
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Maryland
-
Baltimore, Maryland, 미국, 21229
- Maryland Cardiovascular Specialists - Baltimore
-
Oxon Hill, Maryland, 미국, 20745
- MD Medical Research
-
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Michigan
-
Bloomfield Hills, Michigan, 미국, 48304
- Cardio and Vascular Assoc-CAVA
-
Farmington Hills, Michigan, 미국, 48334
- Millennium Cardiology
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Missouri
-
Kansas City, Missouri, 미국, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, 미국, 63110
- Washington University
-
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Nevada
-
Reno, Nevada, 미국, 89502
- Renown Regional Medical Center
-
-
New York
-
Lake Success, New York, 미국, 11042
- Long Island Cardiovascular Consultants PC
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New York, New York, 미국, 10019
- Mount Sinai Hosp at NYC
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Riverhead, New York, 미국, 11901
- Northwell Health Phys Cardio
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7046
- University Of North Carolina At Chapel Hill
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Pennsylvania
-
Horsham, Pennsylvania, 미국, 19044
- AMS Cardiology
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Philadelphia, Pennsylvania, 미국, 19104
- Univ of Pennsylvania Hospital
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Texas
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Amarillo, Texas, 미국, 79106
- PharmaTex Research
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Dallas, Texas, 미국, 75390-9302
- University of Texas Southwestern Medical Center
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El Paso, Texas, 미국, 79905
- David Turbay, MD, PLLC
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Katy, Texas, 미국, 77493
- Private Practice Leadership LLC.
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San Antonio, Texas, 미국, 78212
- Clinical Advancement Center
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San Antonio, Texas, 미국, 78212
- Clinical Advancement Ctr, PLLC
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Sherman, Texas, 미국, 75090
- Sherman Clinical Research
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Tomball, Texas, 미국, 77375
- Northwest Heart Center
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Virginia
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Norfolk, Virginia, 미국, 23507
- Sentara Health Research Center
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Richmond, Virginia, 미국, 23219
- Virginia Commonwealth University
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Blagoevgrad, 불가리아, 2700
- MHAT Puls AD, Cardiology Department
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Haskovo, 불가리아, 6300
- MHAT Haskovo AD
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Pleven, 불가리아, 5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
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Plovdiv, 불가리아, 4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
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Sofia, 불가리아, 1784
- Medical Center Synexus Sofia EOOD
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Sofia, 불가리아, 1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
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Sofia, 불가리아, 1510
- MC Hera EOOD - Sofia
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Sofia, 불가리아, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, 불가리아, 1606
- UMHATEM N.I. Pirogov EAD
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Madrid, 스페인, 28007
- Hospital Gregorio Marañón
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Madrid, 스페인, 28034
- Hospital Ramón y Cajal
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Sanlúcar de Barrameda, 스페인, 11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
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Santiago de Compostela, 스페인, 15706
- Complejo Hospitalario Universitario de Santiago
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Seville, 스페인, 41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
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Valencia, 스페인, 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, 스페인, 41950
- Hospital Vithas Sevilla
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Castille and León
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Salamanca, Castille and León, 스페인, 37007
- Hospital Universitario de Salamanca
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Madrid
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Majadahonda, Madrid, 스페인, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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-
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-
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Buenos Aires, 아르헨티나, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, 아르헨티나, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
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Buenos Aires, 아르헨티나, C1119ACN
- CIPREC Pueyrredon
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CABA, 아르헨티나, C1061AAS
- CIPREC Arenales
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Esperanza, Santa Fe, 아르헨티나, S3080BQV
- Sanatorio Esperanza
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Morón, 아르헨티나, B1708IFF
- Consultorio Integral de Atención al Diabético
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Salta, 아르헨티나, 4400
- Centro Cardiovascular Salta
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San Miguel de Tucumán, Tucumán., 아르헨티나, T4000
- Investigaciones Clinicas Tucuman
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Buenos Aires
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City of Buenos Aires, Buenos Aires, 아르헨티나, C1425
- Cardiología Palermo
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Lanús Este, Buenos Aires, 아르헨티나, B1824KAJ
- Centro Médico CIMEL
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Birmingham, 영국, B21 9RY
- FutureMeds
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Dundee, 영국, DD2 1GZ
- Ninewells Hospital
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Peterborough, 영국, PE3 9GZ
- Peterborough City Hospital
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Highland
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Inverness, Highland, 영국, IV2 3JH
- Raigmore Hospital
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West Sussex
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Chichester, West Sussex, 영국, PO19 6SE
- St. Richard's Hospital_Cardiology
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, 인도, 520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Visakhapatnam, Andhra Pradesh, 인도, 530002
- King George Hospital
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Gujarat
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Vadodara, Gujarat, 인도, 390022
- Rhythm Heart Institute
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Karnataka
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Belagavi, Karnataka, 인도, 590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
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Belagavi, Karnataka, 인도, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
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Bengaluru, Karnataka, 인도, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, 인도, 560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
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Mysuru, Karnataka, 인도, 570015
- Manipal Hospital, Mysuru
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Udupi, Karnataka, 인도, 576104
- Kasturba Medical College and Hospital, Manipal
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Maharashtra
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Nagpur, Maharashtra, 인도, 441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
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Nagpur, Maharashtra, 인도, 440033
- Sengupta Hospital and Research Institute
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Nashik, Maharashtra, 인도, 422005
- Vijan Hospital & Research Centre
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Nashik, Maharashtra, 인도, 422005
- Chopda Medicare and Research Centre Pvt. Ltd.
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Pune, Maharashtra, 인도, 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, 인도, 110029
- All India Institute of Medical Sciences (AIIMS)
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New Delhi, National Capital Territory of Delhi, 인도, 110060
- Sir Ganga Ram Hospital
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New Delhi, National Capital Territory of Delhi, 인도, 110002
- G B Pant Institute of Postgraduate Medical Education and Research
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New Delhi, National Capital Territory of Delhi, 인도, 110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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New Delhi, National Capital Territory of Delhi, 인도, 110093
- Rajiv Gandhi Super Speciality Hospital
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Odisha
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Bhubaneswar, Odisha, 인도, 751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Rajasthan
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Bikaner, Rajasthan, 인도, 334003
- S.P. Medical College & Associated Group of Hospitals
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Tamil Nadu
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Puducherry, Tamil Nadu, 인도, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
-
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Telangana
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Hyderabad, Telangana, 인도, 500020
- Guru Nanak CARE Hospitals
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Hyderabad, Telangana, 인도, 500055
- Malla Reddy Narayana Multispeciality Hospital
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Uttar Pradesh
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Aligarh, Uttar Pradesh, 인도, 202002
- Jawaharlal Nehru Medical College and Hospital
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Kanpur, Uttar Pradesh, 인도, 208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
-
Lucknow, Uttar Pradesh, 인도, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
-
Lucknow, Uttar Pradesh, 인도, 226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
-
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Utter Pradesh
-
Aligarh, Utter Pradesh, 인도, 202002
- Jawaharlal Nehru Medical College and Hospital
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West Bengal
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Kolkata, West Bengal, 인도, 700027
- B M Birla Heart Research Centre
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-
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-
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Benešov, 체코, 256 01
- Innera s.r.o.
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Brno, 체코, 612 00
- Kardiologicka ambulance Brno s.r.o.
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Brno, 체코, 61500
- Vojenská nemocnice Brno p.o.
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Chomutov, 체코, 430 02
- Ordinace pro choroby srdce
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Prague, 체코, 170 00
- MEDICON a.s.
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Svitavy, 체코, 568 25
- Svitavska nemocnice Kardiologie
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Trutnov, 체코, 541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
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Třinec, 체코, 739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
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-
-
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Québec, 캐나다, G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
-
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Alberta
-
Calgary, Alberta, 캐나다, T2N 4Z6
- University of Calgary_Calgary
-
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Ontario
-
Cambridge, Ontario, 캐나다, N1R 6V6
- Cambridge Cardiac Care Centre
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Cambridge, Ontario, 캐나다, N1R 7R1
- Saul Vizel Pro. Med. Corp
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Scarborough Village, Ontario, 캐나다, M1B 5N1
- Corcare Cardiovascular Research
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Toronto, Ontario, 캐나다, M6G 1M2
- Diabetes Heart Research Centre
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Waterloo, Ontario, 캐나다, N2T 0C1
- CPS Research
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Waterloo, Ontario, 캐나다, N2T OC1
- Clinical Research Solutions Inc.
-
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Quebec
-
Montreal, Quebec, 캐나다, H1T 1C8
- Institut de Cardiologie de Montreal
-
Montreal, Quebec, 캐나다, H3G 1A4
- Montreal General Hospital
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-
-
-
-
Adana, 터키 (Türkiye), 01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
-
Adana, 터키 (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
-
Afyonkarahisar, 터키 (Türkiye), 03200
- Afyonkarahisar Health Sciences University
-
Afyonkarahisar, 터키 (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
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Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
-
Ankara, 터키 (Türkiye), 06800
- Ankara Sehir Hastanesi Cardiology
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Bursa, 터키 (Türkiye), 16110
- Bursa Şehir Hastanesi- Kardiyoloji
-
Edirne, 터키 (Türkiye), 22030
- Trakya University
-
Edirne, 터키 (Türkiye), 22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
-
Istanbul, 터키 (Türkiye), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
-
Kayseri, 터키 (Türkiye), 38039
- Erciyes University Cardiology
-
Kayseri, 터키 (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
-
Kocaeli, 터키 (Türkiye), 41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
-
-
Odunpazari
-
Eskişehir, Odunpazari, 터키 (Türkiye), 26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
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-
-
-
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Guilhufe - Penafiel, 포르투갈, 4560-136
- CHTâmega e Sousa - Hospital Padre Américo
-
Lisbon, 포르투갈, 1500-650
- Hospital da Luz
-
Lisbon, 포르투갈, 1649-035
- Centro Hospitalar Lisboa Norte
-
Lisbon, 포르투갈, 1449-005
- CHLO, EPE - Hospital São Francisco Xavier
-
Setúbal, 포르투갈, 2910-446
- Centro Hospitalar de Setubal
-
-
-
-
-
Bielsko-Biala, 폴란드, 43-316
- American Heart of Poland S.A.
-
Bydgoszcz, 폴란드, 85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
-
Gdynia, 폴란드, 81-348
- Szpitale Pomorskie Sp. z o.o.
-
Lublin, 폴란드, 20-601
- Zanamed Medical Clinic Sp. z o.o.
-
Piotrkow Trybunalski, 폴란드, 97-300
- Trialmed Sp. z o. o.
-
Poznan, 폴란드, 61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
-
Tychy, 폴란드, 43-100
- American Heart of Poland S.A.
-
Warsaw, 폴란드, 02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-605
- Centrum Medyczne Intercor Sp. z o.o.
-
Włocławek, Kuyavian-Pomeranian Voivodeship, 폴란드, 87-800
- Kardio Life
-
Włocławek, Kuyavian-Pomeranian Voivodeship, 폴란드, 87-800
- Kardio Life - Tomasz Borkowski
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, 폴란드, 30-721
- Linden sp. z o.o. sp. k.
-
Krakow, Lesser Poland Voivodeship, 폴란드, 30-002
- Cardiomedicum Sp. z o.o.
-
Oświęcim, Lesser Poland Voivodeship, 폴란드, 32-600
- Formed 2 Sp. z o.o.
-
-
Lower Silesian Voivodeship
-
Jelenia Góra, Lower Silesian Voivodeship, 폴란드, 58-506
- Pratia S.A.
-
Wroclaw, Lower Silesian Voivodeship, 폴란드, 50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Lublin Voivodeship
-
Puławy, Lublin Voivodeship, 폴란드, 24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
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Masovian Voivodeship
-
Żyrardów, Masovian Voivodeship, 폴란드, 96-300
- Prywatna Praktyka Lekarska Anna Chudoba
-
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Podlaskie Voivodeship
-
Bialystok, Podlaskie Voivodeship, 폴란드, 15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
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Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, 폴란드, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
-
Gdynia, Pomeranian Voivodeship, 폴란드, 81-348
- Szpitale Pomorskie Sp. z o.o.
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, 폴란드, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
Lodz, Łódź Voivodeship, 폴란드, 90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
-
-
-
-
-
Chambray-lès-Tours, 프랑스, 37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
-
Poitiers, 프랑스, 86000
- Centre Hospitalier Universitaire de Poitiers
-
Rennes, 프랑스, 35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, 프랑스, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
-
Toulon, 프랑스, 83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
-
Valenciennes, 프랑스, 59300
- Polyclinique Vauban
-
Vandœuvre-lès-Nancy, 프랑스, 54500
- Chru de Nancy - Hopital Brabois
-
-
-
-
Australian Capital Territory
-
Garran, Australian Capital Territory, 호주, 2605
- Canberra Hospital
-
-
New South Wales
-
New Lambton Heights, New South Wales, 호주, 2305
- John Hunter Hospital
-
New Lambton Heights, New South Wales, 호주, 2305
- John Hunter Hospital - Cardiovascular Department
-
Wollongong, New South Wales, 호주, 2500
- Illawarra Heart Health Centre
-
-
Queensland
-
Brisbane, Queensland, 호주, 4032
- The Prince Charles Hospital
-
Chermside, Queensland, 호주, 4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
-
-
Victoria
-
Ballarat, Victoria, 호주, 3350
- Ballarat Base Hospital
-
Epping, Victoria, 호주, 3076
- The Cardiologists Pty Ltd
-
Epping, Victoria, 호주, 3076
- Northern Private Hospital Epping - The Cardiologists
-
Mulgrave, Victoria, 호주, 3170
- Advara HeartCare Mulgrave
-
Mulgrave, Victoria, 호주, 3170
- Advara HeartCare
-
-
Western Australia
-
Murdoch, Western Australia, 호주, 6150
- Fiona Stanley Hospital Cardiology
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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. |
|
위약 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
기간: 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)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Clinical Transparency dept. 2834, Novo Nordisk A/S
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NN6018-4914
- U1111-1293-7516 (기타 식별자: World Health Organisation (WHO))
- 2023-506988-34 (기타 식별자: European Medical Agency (EMA))
- 2023 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .