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.
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
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There are 159 Locations for this study
Alexander City Alabama, 35010, United States
Fairhope Alabama, 36532, United States
Little Rock Arkansas, 72204, United States
Northridge California, 91325, United States
Orange California, 92868, United States
Pasadena California, 91105, United States
Largo Florida, 33777, United States
Ormond Beach Florida, 32174, United States
Saint Augustine Florida, 32086, United States
Macon Georgia, 31201, United States
Savannah Georgia, 31406, United States
Hazel Crest Illinois, 60429, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21229, United States
Oxon Hill Maryland, 20745, United States
Bloomfield Hills Michigan, 48304, United States
Kansas City Missouri, 64128, United States
Saint Louis Missouri, 63110, United States
Reno Nevada, 89502, United States
Lake Success New York, 11042, United States
New York New York, 10019, United States
Riverhead New York, 11901, United States
Chapel Hill North Carolina, 27599, United States
Horsham Pennsylvania, 19044, United States
Philadelphia Pennsylvania, 19104, United States
Amarillo Texas, 79106, United States
Dallas Texas, 75390, United States
El Paso Texas, 79905, United States
Katy Texas, 77493, United States
San Antonio Texas, 78212, United States
San Antonio Texas, 78212, United States
Sherman Texas, 75092, United States
Tomball Texas, 77375, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Lanus Este Buenos Aires, B1824, Argentina
Buenos Aires , B1878, Argentina
Buenos Aires , C1425, Argentina
Caba , C1061, Argentina
Morón , B1708, Argentina
Salta , 4400, Argentina
San Miguel De Tucumán, Tucumán. , T4000, Argentina
New Lambton Heights New South Wales, 2305, Australia
New Lambton Heights New South Wales, 2305, Australia
Wollongong New South Wales, 2500, Australia
Brisbane Queensland, 4032, Australia
Brisbane Queensland, 4032, Australia
Ballarat Victoria, 3350, Australia
Epping Victoria, 3076, Australia
Epping Victoria, 3076, Australia
Murdoch Western Australia, 6150, Australia
Haskovo , 6300, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1510, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1750, Bulgaria
Calgary Alberta, T2N 4, Canada
Cambridge Ontario, N1R 6, Canada
Cambridge Ontario, N1R 7, Canada
Scarborough Ontario, M1B 5, Canada
Toronto Ontario, M6G 1, Canada
Waterloo Ontario, N2T 0, Canada
Waterloo Ontario, N2T O, Canada
Montreal Quebec, H1T 1, Canada
Montreal Quebec, H3G 1, Canada
Quebec , G1R 2, Canada
Brno , 612 0, Czechia
Brno , 63600, Czechia
Praha 7 , 170 0, Czechia
Svitavy , 568 2, Czechia
Trutnov , 541 0, Czechia
Chambray Les Tours , 37170, France
Poitiers , 86000, France
Rennes , 35000, France
Rouen cedex , 76031, France
Toulon , 83100, France
Vandoeuvre Les Nancy , 54500, France
Dresden , 01307, Germany
Elsterwerda , 04910, Germany
Frankfurt , 60389, Germany
Freiburg , 79106, Germany
Homburg , 66424, Germany
Kaiserslautern , 67655, Germany
Athens Attiki, GR115, Greece
Athens , 10676, Greece
Athens , 11527, Greece
Athens , GR-14, Greece
Athens , GR-15, Greece
Chaidari, Athens , GR-12, Greece
Chios , GR821, Greece
Larissa , GR-41, Greece
Marousi , 151 2, Greece
Thessaloniki , 54636, Greece
Thessaloniki , GR-57, Greece
Thessaloniki , GR546, Greece
Vijaywada Andhra Pradesh, 52000, India
Visakhapatnam Andra Pradesh, 53000, India
New Delhi Delhi, 11000, India
New Delhi Delhi, 11002, India
New Delhi Delhi, 11002, India
New Delhi Delhi, 11006, India
New Delhi Delhi, 11009, India
Vadodara Gujarat, 39002, India
Belagavi Karnataka, 59001, India
Bengaluru Karnataka, 56003, India
Bengaluru Karnataka, 56006, India
Mysuru Karnataka, 57001, India
Udupi Karnataka, 57610, India
Nagpur Maharashtra, 44003, India
Nagpur Maharashtra, 44110, India
Nashik Maharashtra, 42200, India
Nashik Maharashtra, 42200, India
Nashik Maharashtra, 42200, India
Pune Maharashtra, 41102, India
Bhubaneswar Odisha, 75101, India
Bikaner Rajasthan, 33400, India
Bikaner Rajasthan, 33400, India
Hyderabad Telangana, 50002, India
Hyderabad Telangana, 50005, India
Kanpur Uttar Pradesh, 20800, India
Lucknow Uttar Pradesh, 22601, India
Lucknow Uttar Pradesh, 22601, India
Kolkata West Bengal, 70002, India
Puducherry , 60500, India
Johor Bahru Johor, 80100, Malaysia
Alor Setar Kedah, 05460, Malaysia
Kuantan Pahang, 25100, Malaysia
Ipoh Perak, 30540, Malaysia
Kuala Lumpur Wilayah Persekutuan Kuala Lumpur, 59100, Malaysia
Kajang , 43000, Malaysia
Kota Bharu, Kelantan , 15586, Malaysia
Jelenia Góra Dolnoslaskie, 58-50, Poland
Bydgoszcz Kujawsko-Pomorskie, 85-60, Poland
Lodz Lodzkie, 90-54, Poland
Pulawy Lubelskie, 24-10, Poland
Kraków Malopolskie, 30-00, Poland
Oswiecim Malopolskie, 32-60, Poland
Białystok Podlaskie, 15-54, Poland
Gdynia Pomorskie, 81-34, Poland
Bydgoszcz , 85-68, Poland
Gdynia , 81-15, Poland
Gdynia , 81-34, Poland
Poznan , 61-84, Poland
Warszawa , 02-50, Poland
Guilhufe - Penafiel , 4560-, Portugal
Lisboa , 1500-, Portugal
Lisboa , 1649-, Portugal
Lisbon , 1449-, Portugal
Setubal , 2910-, Portugal
Salamanca Castilla Y León, 37007, Spain
Madrid , 28034, Spain
Sanlúcar de Barrameda , 11540, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41003, Spain
Sevilla , 41950, Spain
Valencia , 46010, Spain
Adana , 01000, Turkey
Afyon , 03200, Turkey
Ankara , 06800, Turkey
Bursa , 16110, Turkey
Edirne , 22030, Turkey
Istanbul , 34480, Turkey
Kayseri , 38039, Turkey
Kocaeli , 41380, Turkey
Inverness Highland, IV2 3, United Kingdom
Dundee , DD1 9, United Kingdom
Peterborough , PE3 9, United Kingdom
West Sussex , PO19 , United Kingdom
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