A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

NCT06200207 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: NN6018-4914U1111-1293-75162023-506988-34
• Study Type: interventional
• Target: 680
• Locations: 16 countries
• Sites: 217

Brief Summary

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.

Conditions

Heart Failure; Systemic Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)

  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)

Secondary Outcomes (10)

• Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)

  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)

  From randomisation (month 0) to end-of-treatment (month 12)

• Participants improving 5 points or more in KCCQ-CSS (yes/no)

  From randomisation (month 0) to end-of-treatment (month 12)

• Participants improving 10 points or more in KCCQ-CSS (yes/no)

  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)

  From randomisation (month 0) to end-of-treatment (month 12)

Study Arms (2)

Ziltivekimab

ACTIVE COMPARATOR

Participants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.

Drug: Ziltivekimab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.

Drug: Placebo

Interventions

Ziltivekimab DRUG

Zilitivekimab will be administered subcutaneously once-monthly.

Ziltivekimab

Placebo DRUG

Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 centimeter (cm)
• LA length greater than or equal to 5.0 cm
• LA area greater than or equal to 20 square centimeter (cm\^2)
• LA volume greater than or equal to 55 milliliter (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 gram 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 centimeter per second (cm/s)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (217)

Advanced Cardiovascular, LLC

Alexander City, Alabama, 35010, United States

Location

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, 36532, United States

Location

Cardiology & Medicine Clinic

Little Rock, Arkansas, 72204, United States

Location

Valley Clinical Trials, Inc.

Northridge, California, 91325, United States

Location

UCI Health

Orange, California, 92868, United States

Location

South California Heart Spc

Pasadena, California, 91105, United States

Location

Clearwater Cardiovascular Consultants

Largo, Florida, 33777, United States

Location

Ocala Cardiovascular Research

Ocala, Florida, 34471, United States

Location

Ormond Beach Clinical Research

Ormond Beach, Florida, 32174, United States

Location

St Johns Ctr Clin Rsch-St. Aug

Saint Augustine, Florida, 32086, United States

Location

GA Arrhythmia Cons & Rsch Inst

Macon, Georgia, 31201, United States

Location

Velocity Clin Rsrch - Savannah

Savannah, Georgia, 31406, United States

Location

Chicago Medical Research LLC

Hazel Crest, Illinois, 60429, United States

Location

UofL Health Care Outpatient

Louisville, Kentucky, 40202, United States

Location

Maryland Cardiovascular Specialists - Baltimore

Baltimore, Maryland, 21229, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Cardio and Vascular Assoc-CAVA

Bloomfield Hills, Michigan, 48304, United States

Location

Millennium Cardiology

Farmington Hills, Michigan, 48334, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Long Island Cardiovascular Consultants PC

Lake Success, New York, 11042, United States

Location

Mount Sinai Hosp at NYC

New York, New York, 10019, United States

Location

Northwell Health Phys Cardio

Riverhead, New York, 11901, United States

Location

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599-7046, United States

Location

AMS Cardiology

Horsham, Pennsylvania, 19044, United States

Location

Univ of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

PharmaTex Research

Amarillo, Texas, 79106, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-9302, United States

Location

David Turbay, MD, PLLC

El Paso, Texas, 79905, United States

Location

Private Practice Leadership LLC.

Katy, Texas, 77493, United States

Location

Clinical Advancement Center

San Antonio, Texas, 78212, United States

Location

Clinical Advancement Ctr, PLLC

San Antonio, Texas, 78212, United States

Location

Sherman Clinical Research

Sherman, Texas, 75090, United States

Location

Northwest Heart Center

Tomball, Texas, 77375, United States

Location

Sentara Health Research Center

Norfolk, Virginia, 23507, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Cardiología Palermo

City of Buenos Aires, Buenos Aires, C1425, Argentina

Location

Centro Médico CIMEL

Lanús Este, Buenos Aires, B1824KAJ, Argentina

Location

Instituto de Investigaciones Clinicas Quilmes SRL

Buenos Aires, B1878GEG, Argentina

Location

CIPREC Pueyrredon

Buenos Aires, C1119ACN, Argentina

Location

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, C1425AGC, Argentina

Location

CIPREC Arenales

CABA, C1061AAS, Argentina

Location

Sanatorio Esperanza

Esperanza, Santa Fe, S3080BQV, Argentina

Location

Consultorio Integral de Atención al Diabético

Morón, B1708IFF, Argentina

Location

Centro Cardiovascular Salta

Salta, 4400, Argentina

Location

Investigaciones Clinicas Tucuman

San Miguel de Tucumán, Tucumán., T4000, Argentina

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

John Hunter Hospital - Cardiovascular Department

New Lambton Heights, New South Wales, 2305, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Illawarra Heart Health Centre

Wollongong, New South Wales, 2500, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

The Prince Charles Hospital - Cardiology Clinical Research Centre

Chermside, Queensland, 4032, Australia

Location

Ballarat Base Hospital

Ballarat, Victoria, 3350, Australia

Location

Northern Private Hospital Epping - The Cardiologists

Epping, Victoria, 3076, Australia

Location

The Cardiologists Pty Ltd

Epping, Victoria, 3076, Australia

Location

Advara HeartCare Mulgrave

Mulgrave, Victoria, 3170, Australia

Location

Advara HeartCare

Mulgrave, Victoria, 3170, Australia

Location

Fiona Stanley Hospital Cardiology

Murdoch, Western Australia, 6150, Australia

Location

MHAT Puls AD, Cardiology Department

Blagoevgrad, 2700, Bulgaria

Location

MHAT Haskovo AD

Haskovo, 6300, Bulgaria

Location

MHAT Heart and Brain EAD - Pleven, Cardiology

Pleven, 5804, Bulgaria

Location

UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology

Plovdiv, 4002, Bulgaria

Location

MC Hera EOOD - Sofia

Sofia, 1510, Bulgaria

Location

Medical center ISUL - Tsaritsa Yoanna EOOD

Sofia, 1527, Bulgaria

Location

UMHATEM N.I. Pirogov EAD

Sofia, 1606, Bulgaria

Location

MHAT Sveta Anna Sofia AD, Clinic of Cardiology

Sofia, 1750, Bulgaria

Location

Medical Center Synexus Sofia EOOD

Sofia, 1784, Bulgaria

Location

University of Calgary_Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Cambridge Cardiac Care Centre

Cambridge, Ontario, N1R 6V6, Canada

Location

Saul Vizel Pro. Med. Corp

Cambridge, Ontario, N1R 7R1, Canada

Location

Corcare Cardiovascular Research

Scarborough Village, Ontario, M1B 5N1, Canada

Location

Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada

Location

CPS Research

Waterloo, Ontario, N2T 0C1, Canada

Location

Clinical Research Solutions Inc.

Waterloo, Ontario, N2T OC1, Canada

Location

Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

CHU de Quebec-Uni Laval-Hotel

Québec, G1R 2J6, Canada

Location

Innera s.r.o.

Benešov, 256 01, Czechia

Location

Kardiologicka ambulance Brno s.r.o.

Brno, 612 00, Czechia

Location

Vojenská nemocnice Brno p.o.

Brno, 61500, Czechia

Location

Ordinace pro choroby srdce

Chomutov, 430 02, Czechia

Location

MEDICON a.s.

Prague, 170 00, Czechia

Location

Svitavska nemocnice Kardiologie

Svitavy, 568 25, Czechia

Location

Kardiologická ambulance MUDr. Ferkl s.r.o.

Trutnov, 541 01, Czechia

Location

Nemocnice AGEL Třinec-Podlesí a.s.

Třinec, 739 61, Czechia

Location

Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau

Chambray-lès-Tours, 37170, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

Rennes, 35000, France

Location

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

Rouen, 76031, France

Location

Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse

Toulon, 83100, France

Location

Polyclinique Vauban

Valenciennes, 59300, France

Location

Chru de Nancy - Hopital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Kardiologisch-Angiologische Praxis Herzzentrum Bremen

Bremen, 28277, Germany

Location

Uniklinik TU Dresden - Herzzentrum Dresden GmbH

Dresden, 01307, Germany

Location

Zentrum für klinische Studien Südbrandenburg GmbH

Elsterwerda, 04910, Germany

Location

Kath. Hospitalvereinigung Thüringen gGmbH - KKH St. Johann Nepomuk - Innere Med. II

Erfurt, 99097, Germany

Location

MVZ CCB Frankfurt und Main-Taunus GbR

Frankfurt, 60389, Germany

Location

Universitätsklinikum Freiburg - Medical Center

Freiburg im Breisgau, 79106, Germany

Location

MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien

Fulda, 36037, Germany

Location

Universität des Saarlandes - Innere Med. III

Homburg, 66421, Germany

Location

Kardiopraxis Schirmer

Kaiserslautern, 67655, Germany

Location

Gesundheitscentrum Mainz (Regner / Schmitt)

Mainz, 55116, Germany

Location

Alexandra General Hospital, Therapeutic Clinic

Athens, Attica, 11528, Greece

Location

Evangelismos Hospital

Athens, 10676, Greece

Location

Naval Hospital of Athens - Clinic of Cardiology

Athens, 11521, Greece

Location

"Laiko" General Hospital of Athens

Athens, 11527, Greece

Location

'G. Gennimatas' General Hospital of Athens - Cardiology Department

Athens, 11527, Greece

Location

'G. Gennimatas' General Hospital of Athens

Athens, 11527, Greece

Location

Konstantopouleio G.H. of Athens, "Agia Olga"

Athens, 14233, Greece

Location

"Hygeia" General Hospital of Athens

Athens, 15123, Greece

Location

Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A. - Cardiology Clinic

Athens, 15562, Greece

Location

Naval Hospital of Athens

Athens, GR-11521, Greece

Location

U.G.H of Athens "Attikon"

Chaidari, Athens, 12462, Greece

Location

U.G.H of Athens "Attikon"

Chaidari, Athens, GR-12462, Greece

Location

General Hospital of Kalamata - Cardiology Department

Chalcis, 34100, Greece

Location

General Hospital of Chios "Skilitsio" - Cardiology Clinic

Chios, 82100, Greece

Location

Univ Gen Hospital Larisa, Cardiology Medicine Clinic

Larissa, 41110, Greece

Location

Sismanogleio General Hospital - Cardiology Department

Marousi, 151 26, Greece

Location

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, 54636, Greece

Location

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

Location

Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt

Thessaloniki, 57010, Greece

Location

Government Siddhartha Medical College & Government General Hospital, Vijayawada

Vijayawada, Andhra Pradesh, 520008, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Rhythm Heart Institute

Vadodara, Gujarat, 390022, India

Location

KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

Belagavi, Karnataka, 590010, India

Location

St John's Medical College Hospital

Bengaluru, Karnataka, 560034, India

Location

Sri Jayadeva Institute of Cardiovascular Sciences & Research

Bengaluru, Karnataka, 560069, India

Location

Manipal Hospital, Mysuru

Mysuru, Karnataka, 570015, India

Location

Kasturba Medical College and Hospital, Manipal

Udupi, Karnataka, 576104, India

Location

Sengupta Hospital and Research Institute

Nagpur, Maharashtra, 440033, India

Location

All India Institute of Medical Sciences (AIIMS), Nagpur

Nagpur, Maharashtra, 441108, India

Location

Chopda Medicare and Research Centre Pvt. Ltd.

Nashik, Maharashtra, 422005, India

Location

Vijan Hospital & Research Centre

Nashik, Maharashtra, 422005, India

Location

Villoo Poonawalla Memorial Hospital

Pune, Maharashtra, 411028, India

Location

G B Pant Institute of Postgraduate Medical Education and Research

New Delhi, National Capital Territory of Delhi, 110002, India

Location

All India Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Vardhaman Mahavir Medical College & Safdarjung Hospital

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Rajiv Gandhi Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, 110093, India

Location

All India Institute of Medical Sciences (AIIMS), Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location

S.P. Medical College & Associated Group of Hospitals

Bikaner, Rajasthan, 334003, India

Location

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Puducherry, Tamil Nadu, 605006, India

Location

Guru Nanak CARE Hospitals

Hyderabad, Telangana, 500020, India

Location

Malla Reddy Narayana Multispeciality Hospital

Hyderabad, Telangana, 500055, India

Location

Jawaharlal Nehru Medical College and Hospital

Aligarh, Uttar Pradesh, 202002, India

Location

Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College

Kanpur, Uttar Pradesh, 208002, India

Location

Dr. Ram Manohar Lohia Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226010, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

Jawaharlal Nehru Medical College and Hospital

Aligarh, Utter Pradesh, 202002, India

Location

B M Birla Heart Research Centre

Kolkata, West Bengal, 700027, India

Location

Hospital Sultanah Aminah

Johor Bahru, Johor, 80100, Malaysia

Location

Hospital Sultanah Bahiyah

Alor Star, Kedah, 05460, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Tengku Ampuan Afzan

Kuantan, Pahang, 25100, Malaysia

Location

Hospital Raja Permaisuri Bainun Ipoh

Ipoh, Perak, 30450, Malaysia

Location

Hospital Serdang

Kajang, Selangor, 43000, Malaysia

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

Centrum Medyczne Intercor Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland

Location

Kardio Life - Tomasz Borkowski

Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

Location

Kardio Life

Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800, Poland

Location

Cardiomedicum Sp. z o.o.

Krakow, Lesser Poland Voivodeship, 30-002, Poland

Location

Linden sp. z o.o. sp. k.

Krakow, Lesser Poland Voivodeship, 30-721, Poland

Location

Formed 2 Sp. z o.o.

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

Pratia S.A.

Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland

Location

4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

Location

Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach

Puławy, Lublin Voivodeship, 24-100, Poland

Location

Prywatna Praktyka Lekarska Anna Chudoba

Żyrardów, Masovian Voivodeship, 96-300, Poland

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Podlaskie Voivodeship, 15-540, Poland

Location

Ind. Spec. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman

Gdynia, Pomeranian Voivodeship, 81-157, Poland

Location

Szpitale Pomorskie Sp. z o.o.

Gdynia, Pomeranian Voivodeship, 81-348, Poland

Location

American Heart of Poland S.A.

Bielsko-Biala, 43-316, Poland

Location

10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy

Bydgoszcz, 85-681, Poland

Location

Szpitale Pomorskie Sp. z o.o.

Gdynia, 81-348, Poland

Location

Zanamed Medical Clinic Sp. z o.o.

Lublin, 20-601, Poland

Location

Trialmed Sp. z o. o.

Piotrkow Trybunalski, 97-300, Poland

Location

Uniwersytecki Szpital Kliniczny W Poznaniu

Poznan, 61-848, Poland

Location

American Heart of Poland S.A.

Tychy, 43-100, Poland

Location

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

Warsaw, 02-507, Poland

Location

Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi

Lodz, Łódź Voivodeship, 90-549, Poland

Location

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

Lodz, Łódź Voivodeship, 93-513, Poland

Location

CHTâmega e Sousa - Hospital Padre Américo

Guilhufe - Penafiel, 4560-136, Portugal

Location

CHLO, EPE - Hospital São Francisco Xavier

Lisbon, 1449-005, Portugal

Location

Hospital da Luz

Lisbon, 1500-650, Portugal

Location

Centro Hospitalar Lisboa Norte

Lisbon, 1649-035, Portugal

Location

Centro Hospitalar de Setubal

Setúbal, 2910-446, Portugal

Location

Hospital Vithas Sevilla

Castilleja de la Cuesta, Andalusia, 41950, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

H Virgen del Camino_Sanlúcar_Medicina Interna

Sanlúcar de Barrameda, 11540, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, 15706, Spain

Location

Clínica Nuevas Tecnologías en Diabetes y Endocrinología

Seville, 41003, Spain

Location

Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)

Valencia, 46010, Spain

Location

Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji

Eskişehir, Odunpazari, 26040, Turkey (Türkiye)

Location

T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan

Adana, 01000, Turkey (Türkiye)

Location

Adana Şehir Eğitim ve Araştırma Hastanesi

Adana, 01060, Turkey (Türkiye)

Location

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji

Afyonkarahisar, 03200, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Kardiyoloji

Ankara, 06800, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi Cardiology

Ankara, 06800, Turkey (Türkiye)

Location

Bursa Şehir Hastanesi- Kardiyoloji

Bursa, 16110, Turkey (Türkiye)

Location

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji

Edirne, 22030, Turkey (Türkiye)

Location

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, 34480, Turkey (Türkiye)

Location

Erciyes University Cardiology

Kayseri, 38039, Turkey (Türkiye)

Location

Erciyes Üniversitesi Hastanesi- Kardiyoloji

Kayseri, 38039, Turkey (Türkiye)

Location

Kocaeli Üniversitesi Hastanesi- Kardiyoloji

Kocaeli, 41380, Turkey (Türkiye)

Location

Raigmore Hospital

Inverness, Highland, IV2 3JH, United Kingdom

Location

St. Richard's Hospital_Cardiology

Chichester, West Sussex, PO19 6SE, United Kingdom

Location

FutureMeds

Birmingham, B21 9RY, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

ziltivekimab

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 8, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

AR (10); MY (9); GB (5); PT (5); CA (10); GR (19); CZ (8); IN (30); TU (14); DE (10); US (37); FR (7); BU (9); ES (9); AU (12); PL (23)