Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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 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)

No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening

Exclusion Criteria:

Medical conditions - cardiovascular:
Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
Medical conditions - infections/immunosuppression:
Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

680

Study ID:

NCT06200207

Recruitment Status:

Recruiting

Sponsor:

Novo Nordisk A/S

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There are 157 Locations for this study

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Advanced Cariodvascular LLC
Alexander City Alabama, 35010, United States
Eastern Shore Rsrch Inst, LLC
Fairhope Alabama, 36532, United States
Cardiology & Medicine Clinic
Little Rock Arkansas, 72204, United States
Valley Clinical Trials, Inc.
Northridge California, 91325, United States
UCI Health
Orange California, 92868, United States
South California Heart Spc
Pasadena California, 91105, United States
Clearwater Cardiovascular Consultants
Largo Florida, 33777, United States
Ormond Beach Clinical Research
Ormond Beach Florida, 32174, United States
St Johns Ctr Clin Rsch-St. Aug
Saint Augustine Florida, 32086, United States
GA Arrhythmia Cons & Rsch Inst
Macon Georgia, 31201, United States
Velocity Clin Rsrch - Savannah
Savannah Georgia, 31406, United States
Chicago Medical Research LLC
Hazel Crest Illinois, 60429, United States
UofL Health Care Outpatient
Louisville Kentucky, 40202, United States
Maryland Cardiovascular Specialists - Baltimore
Baltimore Maryland, 21229, United States
MD Medical Research
Oxon Hill Maryland, 20745, United States
Cardio and Vascular Assoc-CAVA
Bloomfield Hills Michigan, 48304, United States
Kansas City VA Medical Center
Kansas City Missouri, 64128, United States
Washington University
Saint Louis Missouri, 63110, United States
Renown Children's Hospital
Reno Nevada, 89502, United States
Long Island Cardiovascular Consultants PC
Lake Success New York, 11042, United States
Mount Sinai Hosp at NYC
New York New York, 10019, United States
Northwell Health Phys Cardio
Riverhead New York, 11901, United States
University Of North Carolina At Chapel Hill
Chapel Hill North Carolina, 27599, United States
AMS Cardiology
Horsham Pennsylvania, 19044, United States
University of Pennsylvania Hospital
Philadelphia Pennsylvania, 19104, United States
PharmaTex Research
Amarillo Texas, 79106, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
David Turbay, MD, PLLC
El Paso Texas, 79905, United States
Private Practice Leadership LLC.
Katy Texas, 77493, United States
Clinical Advancement Ctr, PLLC
San Antonio Texas, 78212, United States
Sherman Clinical Research
Sherman Texas, 75092, United States
Northwest Heart Center
Tomball Texas, 77375, United States
Sentara Clinical Research
Norfolk Virginia, 23507, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Instituto de Investigaciones Clinicas Quilmes SRL
Buenos Aires , B1878, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires , C1425, Argentina
Centro de Investigación y Prevención Cardiovascular
Caba , C1061, Argentina
Centro Médico CIMEL
Lanus Este , B1824, Argentina
Consultorio Integral de Atención al Diabético
Morón , B1708, Argentina
Centro Cardiovascular Salta
Salta , 4400, Argentina
Investigaciones Clinicas Tucuman
San Miguel De Tucumán, Tucumán. , T4000, Argentina
John Hunter Hospital
New Lambton Heights New South Wales, 2305, Australia
The Prince Charles Hospital
Brisbane Queensland, 4032, Australia
Ballarat Base Hospital
Ballarat Victoria, 3350, Australia
The Cardiologists Pty Ltd
Epping Victoria, 3076, Australia
Fiona Stanley Hospital Cardiology
Murdoch Western Australia, 6150, Australia
MHAT Haskovo AD
Haskovo , 6300, Bulgaria
UMHAT Heart and Brain
Pleven , 5800, Bulgaria
"UMHAT "Sveti Georgi" EAD
Plovdiv , 4002, Bulgaria
"Medical Center Hera" EOOD - Sofia
Sofia , 1510, Bulgaria
Medico-dental center ISUL - Tsaritsa Yoanna EOOD
Sofia , 1527, Bulgaria
"UMHATEM N.I. Pirogov" EAD
Sofia , 1606, Bulgaria
"UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology
Sofia , 1750, Bulgaria
University of Calgary_Calgary
Calgary Alberta, T2N 4, Canada
Cambridge Cardiac Care Centre
Cambridge Ontario, N1R 6, Canada
Saul Vizel Pro. Med. Corp
Cambridge Ontario, N1R 7, Canada
Corcare Cardiovascular Research
Scarborough Ontario, M1B 5, Canada
Diabetes Heart Research Centre
Toronto Ontario, M6G 1, Canada
CPS Research
Waterloo Ontario, N2T 0, Canada
Clinical Research Solutions Inc.
Waterloo Ontario, N2T O, Canada
Institut de Cardiologie de Montreal
Montreal Quebec, H1T 1, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
CHU de Quebec-Uni Laval-Hotel
Quebec , G1R 2, Canada
Kardiologicka ambulance Brno s.r.o.
Brno , 612 0, Czechia
Vojenska nemocnice Brno
Brno , 63600, Czechia
Poliklinika Holešovice VISIONARY - MEDICON a.s.
Praha 7 , 170 0, Czechia
Svitavska nemocnice Kardiologie
Svitavy , 568 2, Czechia
Kardiologie Trutnov Ferkl
Trutnov , 541 0, Czechia
Centre Hospitalier Universitaire de Poitiers
Poitiers , 86000, France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes , 35000, France
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
Rouen cedex , 76031, France
Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
Toulon , 83100, France
Chru de Nancy - Hopital Brabois
Vandoeuvre Les Nancy , 54500, France
Herzzentrum Dresden GmbH Universitätsklinik
Dresden , 01307, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda , 04910, Germany
MVZ CCB Frankfurt Und Main-Taunus GbR
Frankfurt , 60389, Germany
Medical Center - University Of Freiburg
Freiburg , 79106, Germany
UKS - Innere Medizin III
Homburg , 66424, Germany
Kardiopraxis Schirmer
Kaiserslautern , 67655, Germany
Alexandra General Hospital, Therapeutic Clinic
Athens Attiki, GR115, Greece
Evangelismos Hospital
Athens , 10676, Greece
'G. Gennimatas' General Hospital of Athens
Athens , 11527, Greece
Konstantopouleio G.H. of Athens, "Agia Olga"
Athens , GR-14, Greece
"Hygeia" General Hospital of Athens
Athens , GR-15, Greece
U.G.H of Athens "Attikon"
Chaidari, Athens , GR-12, Greece
General Hospital of Chios "Skilitsio"
Chios , GR821, Greece
Univ Gen Hospital Larisa, Cardiology Medicine Clinic
Larissa , GR-41, Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki , 54636, Greece
Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
Thessaloniki , GR-57, Greece
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki , GR546, Greece
Siddhartha Medical College & Government General Hospital
Vijaywada Andhra Pradesh, 52000, India
King George Hospital
Visakhapatnam Andra Pradesh, 53000, India
G B Pant Institute of Postgraduate Medical Education and Research
New Delhi Delhi, 11000, India
All India Institute of Medical Sciences (AIIMS)
New Delhi Delhi, 11002, India
Vardhaman Mahavir Medical College & Safdarjung Hospital
New Delhi Delhi, 11002, India
Sir Ganga Ram Hospital
New Delhi Delhi, 11006, India
Rajiv Gandhi Super Speciality Hospital
New Delhi Delhi, 11009, India
Rhythm Heart Institute
Vadodara Gujarat, 39002, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi Karnataka, 59001, India
St John's Medical College Hospital
Bengaluru Karnataka, 56003, India
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bengaluru Karnataka, 56006, India
Manipal Hospital, Mysuru
Mysuru Karnataka, 57001, India
Kasturba Medical College and Hospital, Manipal
Udupi Karnataka, 57610, India
Sengupta Hospital and Research Institute
Nagpur Maharashtra, 44003, India
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur Maharashtra, 44110, India
Chopda Medicare and Research Centre Pvt. Ltd.
Nashik Maharashtra, 42200, India
Vijan Hospital & Research Centre
Nashik Maharashtra, 42200, India
Vijan Hospital & Research Centre
Nashik Maharashtra, 42200, India
Villoo Poonawalla Memorial Hospital
Pune Maharashtra, 41102, India
All India Institute of Medical Sciences (AIIMS), Bhubaneswar
Bhubaneswar Odisha, 75101, India
S.P. Medical College & Associated Group of Hospitals
Bikaner Rajasthan, 33400, India
Guru Nanak CARE Hospitals
Hyderabad Telangana, 50002, India
Malla Reddy Narayana Multispeciality Hospital
Hyderabad Telangana, 50005, India
Jawaharlal Nehru Medical College and Hospital
Aligarh Uttar Pradesh, 20200, India
Ganesh Shankar Vidyarthe Memorial Medical College (GSVM Medical College)
Kanpur Uttar Pradesh, 20800, India
Dr. Ram Manohar Lohia Institute of Medical Sciences
Lucknow Uttar Pradesh, 22601, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow Uttar Pradesh, 22601, India
B M Birla Heart Research Centre
Kolkata West Bengal, 70002, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Puducherry , 60500, India
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia
Hospital Sultanah Bahiyah
Alor Setar Kedah, 05460, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan Pahang, 25100, Malaysia
Hospital Raja Permaisuri Bainun Ipoh
Ipoh Perak, 30540, Malaysia
University Malaya Medical Centre
Kuala Lumpur Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia
Hospital Serdang
Kajang , 43000, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan , 15586, Malaysia
Pratia S.A.
Jelenia Góra Dolnoslaskie, 58-50, Poland
Centrum Medyczne Intercor Sp. z o.o.
Bydgoszcz Kujawsko-Pomorskie, 85-60, Poland
Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow
Lodz Lodzkie, 90-54, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
Pulawy Lubelskie, 24-10, Poland
Cardiomedicum Sp. z o.o.
Kraków Malopolskie, 30-00, Poland
Formed 2 Sp. z o.o.
Oswiecim Malopolskie, 32-60, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Białystok Podlaskie, 15-54, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia Pomorskie, 81-34, Poland
10 Wojskowy Szpital Kliniczny z Polikliniką - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Bydgoszczy
Bydgoszcz , 85-68, Poland
Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
Gdynia , 81-15, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia , 81-34, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan , 61-84, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warszawa , 02-50, Poland
CHTâmega e Sousa - Hospital Padre Américo
Guilhufe - Penafiel , 4560-, Portugal
Hospital da Luz
Lisboa , 1500-, Portugal
Centro Hospitalar Lisboa Norte
Lisboa , 1649-, Portugal
CHLO, EPE - Hospital São Francisco Xavier
Lisbon , 1449-, Portugal
Centro Hospitalar de Setubal
Setubal , 2910-, Portugal
Hospital Universitario de Salamanca
Salamanca Castilla Y León, 37007, Spain
Hospital Ramón y Cajal
Madrid , 28034, Spain
Hospital Virgen del Camino - Sanlúcar de Barrameda
Sanlúcar de Barrameda , 11540, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela , 15706, Spain
Clínica Nuevas Tecnologías en Diabetes y Endocrinología
Sevilla , 41003, Spain
Hospital Nisa Sevilla Aljarafe
Sevilla , 41950, Spain
Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
Valencia , 46010, Spain
T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
Adana , 01000, Turkey
Afyonkarahisar Health Sciences University
Afyon , 03200, Turkey
Ankara Sehir Hastanesi Cardiology
Ankara , 06800, Turkey
Bursa Sehir Hastanesi Cardiology
Bursa , 16110, Turkey
Trakya University
Edirne , 22030, Turkey
Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul , 34480, Turkey
Erciyes University Cardiology
Kayseri , 38039, Turkey
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli , 41380, Turkey
Raigmore Hospital
Inverness Highland, IV2 3, United Kingdom
Ninewells Hospital
Dundee , DD1 9, United Kingdom
Peterborough City Hospital
Peterborough , PE3 9, United Kingdom
St. Richards Hospital
West Sussex , PO19 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

680

Study ID:

NCT06200207

Recruitment Status:

Recruiting

Sponsor:


Novo Nordisk A/S

How clear is this clinincal trial information?

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