AzTrials
AzTrials

Heart FailurePhase 3ATHENANCT06200207

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

A Phase 3 study testing Ziltivekimab in people with Heart Failure and Systemic Inflammation, run by Novo Nordisk A/S at 217 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Systemic Inflammation
What is being tested?
Ziltivekimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
673 participants
Where
217 sitesin 16 countries
Study dates
1 Apr 2024to 8 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 18Show fewer
  • 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
  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

217 sites in 16 countries.

217 sites in 16 countries

United States37 sites

  • Advanced Cardiovascular, LLC

    Alexander City, Alabama, 35010

  • PharmaTex Research

    Amarillo, Texas, 79106

  • Maryland Cardiovascular Specialists - Baltimore

    Baltimore, Maryland, 21229

  • Cardio and Vascular Assoc-CAVA

    Bloomfield Hills, Michigan, 48304

  • University Of North Carolina At Chapel Hill

    Chapel Hill, North Carolina, 27599-7046

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9302

  • David Turbay, MD, PLLC

    El Paso, Texas, 79905

  • Eastern Shore Rsrch Inst, LLC

    Fairhope, Alabama, 36532

  • Millennium Cardiology

    Farmington Hills, Michigan, 48334

  • Chicago Medical Research LLC

    Hazel Crest, Illinois, 60429

  • AMS Cardiology

    Horsham, Pennsylvania, 19044

  • Kansas City VA Medical Center

    Kansas City, Missouri, 64128

  • Private Practice Leadership LLC.

    Katy, Texas, 77493

  • Long Island Cardiovascular Consultants PC

    Lake Success, New York, 11042

  • Clearwater Cardiovascular Consultants

    Largo, Florida, 33777

  • Cardiology & Medicine Clinic

    Little Rock, Arkansas, 72204

  • UofL Health Care Outpatient

    Louisville, Kentucky, 40202

  • GA Arrhythmia Cons & Rsch Inst

    Macon, Georgia, 31201

  • Mount Sinai Hosp at NYC

    New York, New York, 10019

  • Sentara Health Research Center

    Norfolk, Virginia, 23507

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471

  • UCI Health

    Orange, California, 92868

  • Ormond Beach Clinical Research

    Ormond Beach, Florida, 32174

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • South California Heart Spc

    Pasadena, California, 91105

  • Univ of Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19104

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Northwell Health Phys Cardio

    Riverhead, New York, 11901

  • St Johns Ctr Clin Rsch-St. Aug

    Saint Augustine, Florida, 32086

  • Clinical Advancement Center

    San Antonio, Texas, 78212

  • Clinical Advancement Ctr, PLLC

    San Antonio, Texas, 78212

  • Velocity Clin Rsrch - Savannah

    Savannah, Georgia, 31406

  • Sherman Clinical Research

    Sherman, Texas, 75090

  • Washington University

    St Louis, Missouri, 63110

  • Northwest Heart Center

    Tomball, Texas, 77375

Other trials in United States

India30 sites

  • Jawaharlal Nehru Medical College and Hospital

    Aligarh, Uttar Pradesh, 202002

  • Jawaharlal Nehru Medical College and Hospital

    Aligarh, Utter Pradesh, 202002

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

    Belagavi, Karnataka, 590010

  • KLES Dr. Prabhakar Kore Hospital & Medical Research Centre

    Belagavi, Karnataka, 590010

  • St John's Medical College Hospital

    Bengaluru, Karnataka, 560034

  • Sri Jayadeva Institute of Cardiovascular Sciences & Research

    Bengaluru, Karnataka, 560069

  • All India Institute of Medical Sciences (AIIMS), Bhubaneswar

    Bhubaneswar, Odisha, 751019

  • S.P. Medical College & Associated Group of Hospitals

    Bikaner, Rajasthan, 334003

  • Guru Nanak CARE Hospitals

    Hyderabad, Telangana, 500020

  • Malla Reddy Narayana Multispeciality Hospital

    Hyderabad, Telangana, 500055

  • Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College

    Kanpur, Uttar Pradesh, 208002

  • B M Birla Heart Research Centre

    Kolkata, West Bengal, 700027

  • Dr. Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226010

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

  • Manipal Hospital, Mysuru

    Mysuru, Karnataka, 570015

  • Sengupta Hospital and Research Institute

    Nagpur, Maharashtra, 440033

  • All India Institute of Medical Sciences (AIIMS), Nagpur

    Nagpur, Maharashtra, 441108

  • Chopda Medicare and Research Centre Pvt. Ltd.

    Nashik, Maharashtra, 422005

  • Vijan Hospital & Research Centre

    Nashik, Maharashtra, 422005

  • G B Pant Institute of Postgraduate Medical Education and Research

    New Delhi, National Capital Territory of Delhi, 110002

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029

  • Vardhaman Mahavir Medical College & Safdarjung Hospital

    New Delhi, National Capital Territory of Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Rajiv Gandhi Super Speciality Hospital

    New Delhi, National Capital Territory of Delhi, 110093

  • Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

    Puducherry, Tamil Nadu, 605006

  • Villoo Poonawalla Memorial Hospital

    Pune, Maharashtra, 411028

  • Kasturba Medical College and Hospital, Manipal

    Udupi, Karnataka, 576104

  • Rhythm Heart Institute

    Vadodara, Gujarat, 390022

  • Government Siddhartha Medical College & Government General Hospital, Vijayawada

    Vijayawada, Andhra Pradesh, 520008

  • King George Hospital

    Visakhapatnam, Andhra Pradesh, 530002

Other trials in India

Poland23 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, Podlaskie Voivodeship, 15-540

  • American Heart of Poland S.A.

    Bielsko-Biala, 43-316

  • Centrum Medyczne Intercor Sp. z o.o.

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605

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

    Bydgoszcz, 85-681

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

    Gdynia, Pomeranian Voivodeship, 81-157

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, Pomeranian Voivodeship, 81-348

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81-348

  • Pratia S.A.

    Jelenia Góra, Lower Silesian Voivodeship, 58-506

  • Cardiomedicum Sp. z o.o.

    Krakow, Lesser Poland Voivodeship, 30-002

  • Linden sp. z o.o. sp. k.

    Krakow, Lesser Poland Voivodeship, 30-721

  • Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Lodzi

    Lodz, Łódź Voivodeship, 90-549

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika

    Lodz, Łódź Voivodeship, 93-513

  • Zanamed Medical Clinic Sp. z o.o.

    Lublin, 20-601

  • Formed 2 Sp. z o.o.

    Oświęcim, Lesser Poland Voivodeship, 32-600

  • Trialmed Sp. z o. o.

    Piotrkow Trybunalski, 97-300

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 61-848

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach

    Puławy, Lublin Voivodeship, 24-100

  • American Heart of Poland S.A.

    Tychy, 43-100

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji

    Warsaw, 02-507

  • Kardio Life - Tomasz Borkowski

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Kardio Life

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

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

    Wroclaw, Lower Silesian Voivodeship, 50-981

  • Prywatna Praktyka Lekarska Anna Chudoba

    Żyrardów, Masovian Voivodeship, 96-300

Other trials in Poland

Greece19 sites

  • Alexandra General Hospital, Therapeutic Clinic

    Athens, Attica, 11528

  • Evangelismos Hospital

    Athens, 10676

  • Naval Hospital of Athens - Clinic of Cardiology

    Athens, 11521

  • "Laiko" General Hospital of Athens

    Athens, 11527

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

    Athens, 11527

  • 'G. Gennimatas' General Hospital of Athens

    Athens, 11527

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

    Athens, 14233

  • "Hygeia" General Hospital of Athens

    Athens, 15123

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

    Athens, 15562

  • Naval Hospital of Athens

    Athens, GR-11521

  • U.G.H of Athens "Attikon"

    Chaidari, Athens, 12462

  • U.G.H of Athens "Attikon"

    Chaidari, Athens, GR-12462

  • General Hospital of Kalamata - Cardiology Department

    Chalcis, 34100

  • General Hospital of Chios "Skilitsio" - Cardiology Clinic

    Chios, 82100

  • Univ Gen Hospital Larisa, Cardiology Medicine Clinic

    Larissa, 41110

  • Sismanogleio General Hospital - Cardiology Department

    Marousi, 151 26

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, 54636

  • 'Ippokrateio' General Hospital of Thessaloniki

    Thessaloniki, 54642

  • Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt

    Thessaloniki, 57010

Other trials in Greece

Turkey (Türkiye)14 sites

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

    Adana, 01000

  • Adana Şehir Eğitim ve Araştırma Hastanesi

    Adana, 01060

  • Afyonkarahisar Health Sciences University

    Afyonkarahisar, 03200

  • Afyonkarahisar Sağlık Bilimleri Üniversitesi Sağlık Uygulama Ve Araştırma Merkezi- Kardiyoloji

    Afyonkarahisar, 03200

  • Ankara Bilkent Şehir Hastanesi-Kardiyoloji

    Ankara, 06800

  • Ankara Sehir Hastanesi Cardiology

    Ankara, 06800

  • Bursa Şehir Hastanesi- Kardiyoloji

    Bursa, 16110

  • Trakya University

    Edirne, 22030

  • Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji

    Edirne, 22030

  • Eskişehir Osmangazi Üniversitesi Hastanesi- Kardiyoloji

    Eskişehir, Odunpazari, 26040

  • Başakşehir Çam ve Sakura Şehir Hastanesi

    Istanbul, 34480

  • Erciyes University Cardiology

    Kayseri, 38039

  • Erciyes Üniversitesi Hastanesi- Kardiyoloji

    Kayseri, 38039

  • Kocaeli Üniversitesi Hastanesi- Kardiyoloji

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Australia12 sites

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • The Prince Charles Hospital - Cardiology Clinical Research Centre

    Chermside, Queensland, 4032

  • Northern Private Hospital Epping - The Cardiologists

    Epping, Victoria, 3076

  • The Cardiologists Pty Ltd

    Epping, Victoria, 3076

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Advara HeartCare Mulgrave

    Mulgrave, Victoria, 3170

  • Advara HeartCare

    Mulgrave, Victoria, 3170

  • Fiona Stanley Hospital Cardiology

    Murdoch, Western Australia, 6150

  • John Hunter Hospital - Cardiovascular Department

    New Lambton Heights, New South Wales, 2305

  • John Hunter Hospital

    New Lambton Heights, New South Wales, 2305

  • Illawarra Heart Health Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Argentina10 sites

  • Instituto de Investigaciones Clinicas Quilmes SRL

    Buenos Aires, B1878GEG

  • CIPREC Pueyrredon

    Buenos Aires, C1119ACN

  • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

    Buenos Aires, C1425AGC

  • CIPREC Arenales

    CABA, C1061AAS

  • Cardiología Palermo

    City of Buenos Aires, Buenos Aires, C1425

  • Sanatorio Esperanza

    Esperanza, Santa Fe, S3080BQV

  • Centro Médico CIMEL

    Lanús Este, Buenos Aires, B1824KAJ

  • Consultorio Integral de Atención al Diabético

    Morón, B1708IFF

  • Centro Cardiovascular Salta

    Salta, 4400

  • Investigaciones Clinicas Tucuman

    San Miguel de Tucumán, Tucumán., T4000

Other trials in Argentina

Canada10 sites

  • University of Calgary_Calgary

    Calgary, Alberta, T2N 4Z6

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Saul Vizel Pro. Med. Corp

    Cambridge, Ontario, N1R 7R1

  • Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • CHU de Quebec-Uni Laval-Hotel

    Québec, G1R 2J6

  • Corcare Cardiovascular Research

    Scarborough Village, Ontario, M1B 5N1

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2

  • CPS Research

    Waterloo, Ontario, N2T 0C1

  • Clinical Research Solutions Inc.

    Waterloo, Ontario, N2T OC1

Other trials in Canada

Germany10 sites

  • Kardiologisch-Angiologische Praxis Herzzentrum Bremen

    Bremen, 28277

  • Uniklinik TU Dresden - Herzzentrum Dresden GmbH

    Dresden, 01307

  • Zentrum für klinische Studien Südbrandenburg GmbH

    Elsterwerda, 04910

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

    Erfurt, 99097

  • MVZ CCB Frankfurt und Main-Taunus GbR

    Frankfurt, 60389

  • Universitätsklinikum Freiburg - Medical Center

    Freiburg im Breisgau, 79106

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

    Fulda, 36037

  • Universität des Saarlandes - Innere Med. III

    Homburg, 66421

  • Kardiopraxis Schirmer

    Kaiserslautern, 67655

  • Gesundheitscentrum Mainz (Regner / Schmitt)

    Mainz, 55116

Other trials in Germany

Bulgaria9 sites

  • MHAT Puls AD, Cardiology Department

    Blagoevgrad, 2700

  • MHAT Haskovo AD

    Haskovo, 6300

  • MHAT Heart and Brain EAD - Pleven, Cardiology

    Pleven, 5804

  • UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Cardiology

    Plovdiv, 4002

  • MC Hera EOOD - Sofia

    Sofia, 1510

  • Medical center ISUL - Tsaritsa Yoanna EOOD

    Sofia, 1527

  • UMHATEM N.I. Pirogov EAD

    Sofia, 1606

  • MHAT Sveta Anna Sofia AD, Clinic of Cardiology

    Sofia, 1750

  • Medical Center Synexus Sofia EOOD

    Sofia, 1784

Other trials in Bulgaria

Malaysia9 sites

  • Hospital Sultanah Bahiyah

    Alor Star, Kedah, 05460

  • Hospital Raja Permaisuri Bainun Ipoh

    Ipoh, Perak, 30450

  • Hospital Sultanah Aminah

    Johor Bahru, Johor, 80100

  • Hospital Serdang

    Kajang, Selangor, 43000

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Kelantan, 15586

  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

  • University Malaya Medical Centre

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Spain9 sites

  • Hospital Vithas Sevilla

    Castilleja de la Cuesta, Andalusia, 41950

  • Hospital Gregorio Marañón

    Madrid, 28007

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

  • H Virgen del Camino_Sanlúcar_Medicina Interna

    Sanlúcar de Barrameda, 11540

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15706

  • Clínica Nuevas Tecnologías en Diabetes y Endocrinología

    Seville, 41003

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

    Valencia, 46010

Other trials in Spain

Czechia8 sites

  • Innera s.r.o.

    Benešov, 256 01

  • Kardiologicka ambulance Brno s.r.o.

    Brno, 612 00

  • Vojenská nemocnice Brno p.o.

    Brno, 61500

  • Ordinace pro choroby srdce

    Chomutov, 430 02

  • MEDICON a.s.

    Prague, 170 00

  • Svitavska nemocnice Kardiologie

    Svitavy, 568 25

  • Nemocnice AGEL Třinec-Podlesí a.s.

    Třinec, 739 61

  • Kardiologická ambulance MUDr. Ferkl s.r.o.

    Trutnov, 541 01

Other trials in Czechia

France7 sites

  • Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau

    Chambray-lès-Tours, 37170

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86000

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35000

  • Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

    Rouen, 76031

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

    Toulon, 83100

  • Polyclinique Vauban

    Valenciennes, 59300

  • Chru de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Portugal5 sites

  • CHTâmega e Sousa - Hospital Padre Américo

    Guilhufe - Penafiel, 4560-136

  • CHLO, EPE - Hospital São Francisco Xavier

    Lisbon, 1449-005

  • Hospital da Luz

    Lisbon, 1500-650

  • Centro Hospitalar Lisboa Norte

    Lisbon, 1649-035

  • Centro Hospitalar de Setubal

    Setúbal, 2910-446

Other trials in Portugal

United Kingdom5 sites

  • FutureMeds

    Birmingham, B21 9RY

  • St. Richard's Hospital_Cardiology

    Chichester, West Sussex, PO19 6SE

  • Ninewells Hospital

    Dundee, DD2 1GZ

  • Raigmore Hospital

    Inverness, Highland, IV2 3JH

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

Other trials in United Kingdom

About this study

Official title: Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

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.

Being tested
Ziltivekimab, Placebo
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZiltivekimabDrug

    Zilitivekimab will be administered subcutaneously once-monthly.

  • PlaceboDrug

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

Study groups in NCT06200207
Study groupRoleWhat they receive
ZiltivekimabActive comparatorParticipants will receive ziltivekimab administered subcutaneously (s.c.) once-monthly and added to standard of care for 12 months.
Receives: Drug: Ziltivekimab
PlaceboPlacebo comparatorParticipants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

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

    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.

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

  2. Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)

    Measured as count of participants.

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

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

    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.

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

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

    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.

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

  5. Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)

    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.

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

  6. Change in six-minute walk distance (6MWD)

    Measured in meters.

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

  7. Change in high-sensitivity C-reactive protein (hs-CRP)

    Measured as ratio to baseline.

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

  8. Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)

    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.

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

  9. Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)

    Measured as ratio to baseline.

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

  10. Change in eGFR (CKD-EPI)

    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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2024
  2. Study start1 Apr 2024
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion8 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
673 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06200207
Sponsor's protocol ID
NN6018-4914
Other IDs
U1111-1293-7516, 2023-506988-34, 2023
Acronym
ATHENA
Status last verified
Sep 2026
First submitted
28 Dec 2023
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ziltivekimab in people with Heart Failure and Systemic Inflammation, run by Novo Nordisk A/S at 217 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 217 sites in United States, India, Poland, Greece, Turkey (Türkiye) and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) (time frame: From randomisation (month 0) to end-of-treatment (month 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06200207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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ATHENA Clinical Trial NCT06200207 | AzTrials