Un estudio de investigación que analiza cómo funciona Ziltivekimab en comparación con el placebo en participantes con insuficiencia cardíaca e inflamación (ATHENA)
30 de septiembre de 2026 actualizado por: Novo Nordisk A/S
Efectos de ziltivekimab versus placebo sobre los síntomas de insuficiencia cardíaca y la función física en pacientes con insuficiencia cardíaca con fracción de eyección levemente reducida o conservada e inflamación sistémica
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.
Descripción general del estudio
Estado
Estado
Activo, no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
673
Fase
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Bremen, Alemania, 28277
- Kardiologisch-Angiologische Praxis Herzzentrum Bremen
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Dresden, Alemania, 01307
- Uniklinik TU Dresden - Herzzentrum Dresden GmbH
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Elsterwerda, Alemania, 04910
- Zentrum für klinische Studien Südbrandenburg GmbH
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Erfurt, Alemania, 99097
- Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II
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Frankfurt, Alemania, 60389
- MVZ CCB Frankfurt und Main-Taunus GbR
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Freiburg im Breisgau, Alemania, 79106
- Universitätsklinikum Freiburg - Medical Center
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Fulda, Alemania, 36037
- MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
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Homburg, Alemania, 66421
- Universität des Saarlandes - Innere Med. III
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Kaiserslautern, Alemania, 67655
- Kardiopraxis Schirmer
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Mainz, Alemania, 55116
- Gesundheitscentrum Mainz (Regner / Schmitt)
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Buenos Aires, Argentina, C1425AGC
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, B1878GEG
- Instituto de Investigaciones Clinicas Quilmes SRL
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Buenos Aires, Argentina, C1119ACN
- CIPREC Pueyrredon
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CABA, Argentina, C1061AAS
- CIPREC Arenales
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Esperanza, Santa Fe, Argentina, S3080BQV
- Sanatorio Esperanza
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Morón, Argentina, B1708IFF
- Consultorio Integral de Atención al Diabético
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Salta, Argentina, 4400
- Centro Cardiovascular Salta
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San Miguel de Tucumán, Tucumán., Argentina, T4000
- Investigaciones Clinicas Tucuman
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Buenos Aires
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City of Buenos Aires, Buenos Aires, Argentina, C1425
- Cardiología Palermo
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Lanús Este, Buenos Aires, Argentina, B1824KAJ
- Centro Médico CIMEL
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Australian Capital Territory
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Garran, Australian Capital Territory, Australia, 2605
- Canberra Hospital
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New South Wales
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New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital
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New Lambton Heights, New South Wales, Australia, 2305
- John Hunter Hospital - Cardiovascular Department
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Wollongong, New South Wales, Australia, 2500
- Illawarra Heart Health Centre
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Queensland
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Brisbane, Queensland, Australia, 4032
- The Prince Charles Hospital
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital - Cardiology Clinical Research Centre
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Victoria
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Ballarat, Victoria, Australia, 3350
- Ballarat Base Hospital
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Epping, Victoria, Australia, 3076
- The Cardiologists Pty Ltd
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Epping, Victoria, Australia, 3076
- Northern Private Hospital Epping - The Cardiologists
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Mulgrave, Victoria, Australia, 3170
- Advara HeartCare Mulgrave
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Mulgrave, Victoria, Australia, 3170
- Advara HeartCare
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital Cardiology
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Blagoevgrad, Bulgaria, 2700
- MHAT Puls AD, Cardiology Department
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Haskovo, Bulgaria, 6300
- MHAT Haskovo AD
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Pleven, Bulgaria, 5804
- MHAT Heart and Brain EAD - Pleven, Cardiology
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Plovdiv, Bulgaria, 4002
- UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology
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Sofia, Bulgaria, 1784
- Medical Center Synexus Sofia EOOD
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Sofia, Bulgaria, 1527
- Medical center ISUL - Tsaritsa Yoanna EOOD
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Sofia, Bulgaria, 1510
- MC Hera EOOD - Sofia
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Sofia, Bulgaria, 1750
- MHAT Sveta Anna Sofia AD, Clinic of Cardiology
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Sofia, Bulgaria, 1606
- UMHATEM N.I. Pirogov EAD
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Québec, Canadá, G1R 2J6
- CHU de Quebec-Uni Laval-Hotel
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Alberta
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Calgary, Alberta, Canadá, T2N 4Z6
- University of Calgary_Calgary
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Ontario
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Cambridge, Ontario, Canadá, N1R 6V6
- Cambridge Cardiac Care Centre
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Cambridge, Ontario, Canadá, N1R 7R1
- Saul Vizel Pro. Med. Corp
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Scarborough Village, Ontario, Canadá, M1B 5N1
- Corcare Cardiovascular Research
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Toronto, Ontario, Canadá, M6G 1M2
- Diabetes Heart Research Centre
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Waterloo, Ontario, Canadá, N2T 0C1
- CPS Research
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Waterloo, Ontario, Canadá, N2T OC1
- Clinical Research Solutions Inc.
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Quebec
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Montreal, Quebec, Canadá, H1T 1C8
- Institut de Cardiologie de Montreal
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Montreal, Quebec, Canadá, H3G 1A4
- Montreal General Hospital
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Benešov, Chequia, 256 01
- Innera s.r.o.
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Brno, Chequia, 612 00
- Kardiologicka ambulance Brno s.r.o.
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Brno, Chequia, 61500
- Vojenská nemocnice Brno p.o.
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Chomutov, Chequia, 430 02
- Ordinace pro choroby srdce
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Prague, Chequia, 170 00
- MEDICON a.s.
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Svitavy, Chequia, 568 25
- Svitavska nemocnice Kardiologie
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Trutnov, Chequia, 541 01
- Kardiologická ambulance MUDr. Ferkl s.r.o.
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Třinec, Chequia, 739 61
- Nemocnice AGEL Třinec-Podlesí a.s.
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Madrid, España, 28007
- Hospital Gregorio Marañón
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Madrid, España, 28034
- Hospital Ramón y Cajal
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Sanlúcar de Barrameda, España, 11540
- H Virgen del Camino_Sanlúcar_Medicina Interna
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Santiago de Compostela, España, 15706
- Complejo Hospitalario Universitario de Santiago
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Seville, España, 41003
- Clínica Nuevas Tecnologías en Diabetes y Endocrinología
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Valencia, España, 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, España, 41950
- Hospital Vithas Sevilla
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Castille and León
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Salamanca, Castille and León, España, 37007
- Hospital Universitario de Salamanca
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Madrid
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Majadahonda, Madrid, España, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Alabama
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Alexander City, Alabama, Estados Unidos, 35010
- Advanced Cardiovascular, LLC
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Fairhope, Alabama, Estados Unidos, 36532
- Eastern Shore Rsrch Inst, LLC
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72204
- Cardiology & Medicine Clinic
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California
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Northridge, California, Estados Unidos, 91325
- Valley Clinical Trials, Inc.
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Orange, California, Estados Unidos, 92868
- UCI Health
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Pasadena, California, Estados Unidos, 91105
- South California Heart Spc
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Florida
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Largo, Florida, Estados Unidos, 33777
- Clearwater Cardiovascular Consultants
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Ocala, Florida, Estados Unidos, 34471
- Ocala Cardiovascular Research
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Ormond Beach, Florida, Estados Unidos, 32174
- Ormond Beach Clinical Research
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Saint Augustine, Florida, Estados Unidos, 32086
- St Johns Ctr Clin Rsch-St. Aug
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Georgia
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Macon, Georgia, Estados Unidos, 31201
- GA Arrhythmia Cons & Rsch Inst
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Savannah, Georgia, Estados Unidos, 31406
- Velocity Clin Rsrch - Savannah
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Illinois
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Hazel Crest, Illinois, Estados Unidos, 60429
- Chicago Medical Research LLC
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- UofL Health Care Outpatient
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Maryland
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Baltimore, Maryland, Estados Unidos, 21229
- Maryland Cardiovascular Specialists - Baltimore
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Oxon Hill, Maryland, Estados Unidos, 20745
- MD Medical Research
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Michigan
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Bloomfield Hills, Michigan, Estados Unidos, 48304
- Cardio and Vascular Assoc-CAVA
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Farmington Hills, Michigan, Estados Unidos, 48334
- Millennium Cardiology
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Missouri
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Kansas City, Missouri, Estados Unidos, 64128
- Kansas City VA Medical Center
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St Louis, Missouri, Estados Unidos, 63110
- Washington University
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Nevada
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Reno, Nevada, Estados Unidos, 89502
- Renown Regional Medical Center
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New York
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Lake Success, New York, Estados Unidos, 11042
- Long Island Cardiovascular Consultants PC
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New York, New York, Estados Unidos, 10019
- Mount Sinai Hosp at NYC
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Riverhead, New York, Estados Unidos, 11901
- Northwell Health Phys Cardio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599-7046
- University Of North Carolina At Chapel Hill
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Pennsylvania
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Horsham, Pennsylvania, Estados Unidos, 19044
- AMS Cardiology
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Univ of Pennsylvania Hospital
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Texas
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Amarillo, Texas, Estados Unidos, 79106
- PharmaTex Research
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Dallas, Texas, Estados Unidos, 75390-9302
- University of Texas Southwestern Medical Center
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El Paso, Texas, Estados Unidos, 79905
- David Turbay, MD, PLLC
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Katy, Texas, Estados Unidos, 77493
- Private Practice Leadership LLC.
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San Antonio, Texas, Estados Unidos, 78212
- Clinical Advancement Center
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San Antonio, Texas, Estados Unidos, 78212
- Clinical Advancement Ctr, PLLC
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Sherman, Texas, Estados Unidos, 75090
- Sherman Clinical Research
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Tomball, Texas, Estados Unidos, 77375
- Northwest Heart Center
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Virginia
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Norfolk, Virginia, Estados Unidos, 23507
- Sentara Health Research Center
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Richmond, Virginia, Estados Unidos, 23219
- Virginia Commonwealth University
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Chambray-lès-Tours, Francia, 37170
- Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
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Poitiers, Francia, 86000
- Centre Hospitalier Universitaire de Poitiers
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Rennes, Francia, 35000
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
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Rouen, Francia, 76031
- Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
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Toulon, Francia, 83100
- Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
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Valenciennes, Francia, 59300
- Polyclinique Vauban
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Vandœuvre-lès-Nancy, Francia, 54500
- Chru de Nancy - Hopital Brabois
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Athens, Grecia, 11527
- "Laiko" General Hospital of Athens
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Athens, Grecia, 10676
- Evangelismos Hospital
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Athens, Grecia, GR-11521
- Naval Hospital of Athens
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Athens, Grecia, 11527
- 'G. Gennimatas' General Hospital of Athens
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Athens, Grecia, 14233
- Konstantopouleio G.H. of Athens, "Agia Olga"
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Athens, Grecia, 15123
- "Hygeia" General Hospital of Athens
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Athens, Grecia, 11527
- 'G. Gennimatas' General Hospital of Athens - Cardiology Department
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Athens, Grecia, 15562
- Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic
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Athens, Grecia, 11521
- Naval Hospital of Athens - Clinic of Cardiology
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Chaidari, Athens, Grecia, GR-12462
- U.G.H of Athens "Attikon"
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Chaidari, Athens, Grecia, 12462
- U.G.H of Athens "Attikon"
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Chalcis, Grecia, 34100
- General Hospital of Kalamata - Cardiology Department
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Chios, Grecia, 82100
- General Hospital of Chios "Skilitsio" - Cardiology Clinic
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Larissa, Grecia, 41110
- Univ Gen Hospital Larisa, Cardiology Medicine Clinic
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Marousi, Grecia, 151 26
- Sismanogleio General Hospital - Cardiology Department
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Thessaloniki, Grecia, 54636
- "AHEPA" University General Hospital of Thessaloniki
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Thessaloniki, Grecia, 54642
- 'Ippokrateio' General Hospital of Thessaloniki
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Thessaloniki, Grecia, 57010
- Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
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Attica
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Athens, Attica, Grecia, 11528
- Alexandra General Hospital, Therapeutic Clinic
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Andhra Pradesh
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Vijayawada, Andhra Pradesh, India, 520008
- Government Siddhartha Medical College & Government General Hospital, Vijayawada
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Visakhapatnam, Andhra Pradesh, India, 530002
- King George Hospital
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Gujarat
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Vadodara, Gujarat, India, 390022
- Rhythm Heart Institute
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Karnataka
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Belagavi, Karnataka, India, 590010
- KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
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Belagavi, Karnataka, India, 590010
- KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
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Bengaluru, Karnataka, India, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, India, 560069
- Sri Jayadeva Institute of Cardiovascular Sciences & Research
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Mysuru, Karnataka, India, 570015
- Manipal Hospital, Mysuru
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Udupi, Karnataka, India, 576104
- Kasturba Medical College and Hospital, Manipal
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Maharashtra
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Nagpur, Maharashtra, India, 441108
- All India Institute of Medical Sciences (AIIMS), Nagpur
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Nagpur, Maharashtra, India, 440033
- Sengupta Hospital and Research Institute
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Nashik, Maharashtra, India, 422005
- Vijan Hospital & Research Centre
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Nashik, Maharashtra, India, 422005
- Chopda Medicare and Research Centre Pvt. Ltd.
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Pune, Maharashtra, India, 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, India, 110029
- All India Institute of Medical Sciences (AIIMS)
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New Delhi, National Capital Territory of Delhi, India, 110060
- Sir Ganga Ram Hospital
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New Delhi, National Capital Territory of Delhi, India, 110002
- G B Pant Institute of Postgraduate Medical Education and Research
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New Delhi, National Capital Territory of Delhi, India, 110029
- Vardhaman Mahavir Medical College & Safdarjung Hospital
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New Delhi, National Capital Territory of Delhi, India, 110093
- Rajiv Gandhi Super Speciality Hospital
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Odisha
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Bhubaneswar, Odisha, India, 751019
- All India Institute of Medical Sciences (AIIMS), Bhubaneswar
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Rajasthan
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Bikaner, Rajasthan, India, 334003
- S.P. Medical College & Associated Group of Hospitals
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Tamil Nadu
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Puducherry, Tamil Nadu, India, 605006
- Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
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Telangana
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Hyderabad, Telangana, India, 500020
- Guru Nanak CARE Hospitals
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Hyderabad, Telangana, India, 500055
- Malla Reddy Narayana Multispeciality Hospital
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Uttar Pradesh
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Aligarh, Uttar Pradesh, India, 202002
- Jawaharlal Nehru Medical College and Hospital
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Kanpur, Uttar Pradesh, India, 208002
- Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
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Lucknow, Uttar Pradesh, India, 226014
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Lucknow, Uttar Pradesh, India, 226010
- Dr. Ram Manohar Lohia Institute of Medical Sciences
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Utter Pradesh
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Aligarh, Utter Pradesh, India, 202002
- Jawaharlal Nehru Medical College and Hospital
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West Bengal
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Kolkata, West Bengal, India, 700027
- B M Birla Heart Research Centre
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Kota Bharu, Kelantan, Malasia, 15586
- Hospital Raja Perempuan Zainab II
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Johor
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Johor Bahru, Johor, Malasia, 80100
- Hospital Sultanah Aminah
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Kedah
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Alor Star, Kedah, Malasia, 05460
- Hospital Sultanah Bahiyah
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Kelantan
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Kota Bharu, Kelantan, Malasia, 15586
- Hospital Raja Perempuan Zainab II
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
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Lembah Pantai, Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malasia, 25100
- Hospital Tengku Ampuan Afzan
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Perak
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Ipoh, Perak, Malasia, 30450
- Hospital Raja Permaisuri Bainun Ipoh
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Selangor
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Kajang, Selangor, Malasia, 43000
- Hospital Serdang
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Bielsko-Biala, Polonia, 43-316
- American Heart of Poland S.A.
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Bydgoszcz, Polonia, 85-681
- 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy
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Gdynia, Polonia, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Lublin, Polonia, 20-601
- Zanamed Medical Clinic Sp. z o.o.
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Piotrkow Trybunalski, Polonia, 97-300
- Trialmed Sp. z o. o.
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Poznan, Polonia, 61-848
- Uniwersytecki Szpital Kliniczny W Poznaniu
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Tychy, Polonia, 43-100
- American Heart of Poland S.A.
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Warsaw, Polonia, 02-507
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
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Kuyavian-Pomeranian Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-605
- Centrum Medyczne Intercor Sp. z o.o.
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polonia, 87-800
- Kardio Life
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Włocławek, Kuyavian-Pomeranian Voivodeship, Polonia, 87-800
- Kardio Life - Tomasz Borkowski
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polonia, 30-721
- Linden sp. z o.o. sp. k.
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Krakow, Lesser Poland Voivodeship, Polonia, 30-002
- Cardiomedicum Sp. z o.o.
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Oświęcim, Lesser Poland Voivodeship, Polonia, 32-600
- Formed 2 Sp. z o.o.
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Lower Silesian Voivodeship
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Jelenia Góra, Lower Silesian Voivodeship, Polonia, 58-506
- Pratia S.A.
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Wroclaw, Lower Silesian Voivodeship, Polonia, 50-981
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
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Lublin Voivodeship
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Puławy, Lublin Voivodeship, Polonia, 24-100
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
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Masovian Voivodeship
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Żyrardów, Masovian Voivodeship, Polonia, 96-300
- Prywatna Praktyka Lekarska Anna Chudoba
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-540
- Uniwersytecki Szpital Kliniczny w Bialymstoku
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Pomeranian Voivodeship
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Gdynia, Pomeranian Voivodeship, Polonia, 81-157
- Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
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Gdynia, Pomeranian Voivodeship, Polonia, 81-348
- Szpitale Pomorskie Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polonia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
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Lodz, Łódź Voivodeship, Polonia, 90-549
- Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi
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Guilhufe - Penafiel, Portugal, 4560-136
- CHTâmega e Sousa - Hospital Padre Américo
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Lisbon, Portugal, 1500-650
- Hospital da Luz
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Lisbon, Portugal, 1649-035
- Centro Hospitalar Lisboa Norte
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Lisbon, Portugal, 1449-005
- CHLO, EPE - Hospital São Francisco Xavier
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Setúbal, Portugal, 2910-446
- Centro Hospitalar de Setubal
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Birmingham, Reino Unido, B21 9RY
- FutureMeds
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Dundee, Reino Unido, DD2 1GZ
- Ninewells Hospital
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Peterborough, Reino Unido, PE3 9GZ
- Peterborough City Hospital
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Highland
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Inverness, Highland, Reino Unido, IV2 3JH
- Raigmore Hospital
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West Sussex
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Chichester, West Sussex, Reino Unido, PO19 6SE
- St. Richard's Hospital_Cardiology
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Adana, Turquía (Türkiye), 01000
- T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
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Adana, Turquía (Türkiye), 01060
- Adana Şehir Eğitim ve Araştırma Hastanesi
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Afyonkarahisar, Turquía (Türkiye), 03200
- Afyonkarahisar Health Sciences University
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Afyonkarahisar, Turquía (Türkiye), 03200
- Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji
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Ankara, Turquía (Türkiye), 06800
- Ankara Bilkent Şehir Hastanesi-Kardiyoloji
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Ankara, Turquía (Türkiye), 06800
- Ankara Sehir Hastanesi Cardiology
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Bursa, Turquía (Türkiye), 16110
- Bursa Şehir Hastanesi- Kardiyoloji
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Edirne, Turquía (Türkiye), 22030
- Trakya University
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Edirne, Turquía (Türkiye), 22030
- Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji
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Istanbul, Turquía (Türkiye), 34480
- Başakşehir Çam ve Sakura Şehir Hastanesi
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Kayseri, Turquía (Türkiye), 38039
- Erciyes University Cardiology
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Kayseri, Turquía (Türkiye), 38039
- Erciyes Üniversitesi Hastanesi- Kardiyoloji
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Kocaeli, Turquía (Türkiye), 41380
- Kocaeli Üniversitesi Hastanesi- Kardiyoloji
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Odunpazari
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Eskişehir, Odunpazari, Turquía (Türkiye), 26040
- Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
-
Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
-
Disease specific - cardiovascular:
-
N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
-
Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
-
Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
-
Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:
- Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m^2)
- LA diameter greater than or equal to 3.8 centimeters (cm)
- LA length greater than or equal to 5.0 cm
- LA area greater than or equal to 20 square centimeters (cm^2)
- LA volume greater than or equal to 55 milliliters (mL)
- Intraventricular septal thickness greater than or equal to 1.1 cm
- Posterior wall thickness greater than or equal to 1.1 cm
- LV mass index greater than or equal to 115 grams per square meter (g/m^2) in men or greater than or equal to 95 g/m^2 in women
h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeters per second (cm/s)
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No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
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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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
|
Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Clinical Transparency dept. 2834, Novo Nordisk A/S
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
1 de abril de 2024
Finalización primaria (Estimado)
Finalización primaria
1 de octubre de 2026
Finalización del estudio (Estimado)
Finalización del estudio
8 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
28 de diciembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
28 de diciembre de 2023
Publicado por primera vez (Actual)
Publicado por primera vez
10 de enero de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
1 de octubre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
30 de septiembre de 2026
Última verificación
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- NN6018-4914
- U1111-1293-7516 (Otro identificador: World Health Organisation (WHO))
- 2023-506988-34 (Otro identificador: European Medical Agency (EMA))
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .