Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.
Inclusion Criteria:
Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular
At least one of the following:
Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class II-IV).
Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) 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 (e.g., 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 meter square (mL/m^2).
LA diameter greater than equal to 3.8 centimeter (cm).
LA length greater than equal to 5.0 cm.
LA area greater than equal to 20 cm square.
LA volume greater than equal to 55 milliters (mL).
Intraventricular septal thickness greater than equal to 1.1 cm.
Posterior wall thickness greater than equal to 1.1 cm.
Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m^2 ) in men or greater than equal to 95 g⁄m^2 in women.
E/e' (mean septal and lateral) greater than equal to 10.
e' (mean septal and lateral) less than 9 centimeter per second (cm/s).
No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).
Exclusion Criteria:
Medical conditions - cardiovascular
Medical conditions - infections/immunosuppression
- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.
CABA, Buenos Aires C1128 AAF, Argentina
CABA, Buenos Aires C1440CFD, Argentina
Mar del Plata, Buenos Aires B7600GNY, Argentina
CABA, Buenos Aires, Argentina C1093AAS, Argentina
CABA, C1093AAS, Argentina
CABA, C1440CFD, Argentina
Concord, New South Wales 2139, Australia
Saint Stefan, 8511, Austria
Vitória, Espírito Santo 29055-450, Brazil
Belo Horizonte, Minas Gerais 30150-320, Brazil
Bragança Paulista, São Paulo 12916-542, Brazil
Ribeirão Preto, São Paulo 14051-140, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Goiânia/GO, 74605-020, Brazil
Marília/SP, 17515-000, Brazil
Porto Alegre/RS, 90840-440, Brazil
Recife/PE, 56517-630, Brazil
São Paulo/SP, 04026-090, Brazil
North York, Ontario M6B 3H7, Canada
Huainan, Anhui 232007, China
Chongqing, Chongqing Municipality 400042, China
Chongqing, Chongqing Municipality 400060, China
Lanzhou, Gansu 730030, China
Shantou, Guangdong 515041, China
Harbin, Heilongjiang 150001, China
Xi'an, Shaanxi 710061, China
Hangzhou, Zhejiang 310003, China
Bucaramanga-piedecuesta, Valle Del Menzuli - Santander, Santander Department 681012, Colombia
Krapinske Toplice, Krapinsko Zagorska County 49217, Croatia
Plzen - Lochotín, 323 00, Czechia
Toulon, 83100, France
Toulouse, 31059, France
Berlin, 13353, Germany
Hamburg, 20246, Germany
Rotenburg A.d. Fulda, 36199, Germany
Ampelokipoi/Athens, 11522, Greece
Chaidari, Athens, 12462, Greece
Pylea, Thessaloniki, 57001, Greece
Rio Patras, 26504, Greece
Rio Patras, GR26504, Greece
Békéscsaba, Bekes County 5600, Hungary
Vijayawada, Andhra Pradesh 520008, India
New Delhi, National Capital Territory of Delhi 110002, India
New Delhi, National Capital Territory of Delhi 110025, India
New Delhi, National Capital Territory of Delhi 110029, India
New Dehli, New Delhi 110029, India
Chandigarh, Punjab 160012, India
Karnataka, 590010, India
Mahon, Cork, T12 K199, Ireland
Beer Yaakov, 7033001, Israel
Casale Monferrato, Al 15033, Italy
Pisa, Pi 56124, Italy
Roma, Rm 00135, Italy
Novara, 28100, Italy
Uwajima-shi, Ehime 798-8510, Japan
Bunkyo-ku, Tokyo, 113-8655, Japan
Fukuoka-shi, Fukuoka, 814-0133, Japan
Hamamatsu-shi, Shizuoka, 430-0929, Japan
Hokkaido, 078-8211, Japan
Kanagawa, 236-0051, Japan
Kitakyushu-shi, Fukuoka, 806-8501, Japan
Morioka-shi, Iwate, 020-0066, Japan
Morioka-shi, Iwate, 020-0066, Japan
Okayama, 700-8557, Japan
Okayama-shi, Okayama, 700-8558, Japan
Osaka, 540-0006, Japan
Osaka, 564-8565, Japan
Takamatsu-shi, Kagawa, 760-8557, Japan
Yamaguchi, 740-8510, Japan
Yokohama-shi, Kanagawa, 234-0054, Japan
Cheras, Kuala Lumpur 56000, Malaysia
Cheras, Kuala Lumpur 56000, Malaysia
Lembah Pantai, Kuala Lumpur 59100, Malaysia
San Nicolás de los Garza, Nuevo León 66465, Mexico
Santiago de Querétaro, Qro., Querétaro 76000, Mexico
San Luis Potosí City, San Luis Potosí 78200, Mexico
Culiacán, Sinaloa 80230, Mexico
Lørenskog, 1478, Norway
Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
Wroclaw, Lower Silesian Voivodeship 50-556, Poland
Wroclaw, Lower Silesian Voivodeship 50-981, Poland
Grodzisk Mazowiecki, Masovian Voivodeship 05-825, Poland
Warsaw, Masovian Voivodeship 00-416, Poland
Bialystok, Podlaskie Voivodeship 15-540, Poland
Gdynia, Pomeranian Voivodeship 81-157, Poland
Katowice, Silesian Voivodeship 40-635, Poland
Rzeszów, 35-111, Poland
Lodz, Łódź Voivodeship 90-549, Poland
Figueira da Foz Municipality, 3094-001, Portugal
Guilhufe - Penafiel, 4560-136, Portugal
Lisbon, 1449-005, Portugal
George, Eastern Cape 6529, South Africa
Samutsakhon, 74120, Thailand
Afyonkarahisar, 03200, Turkey (Türkiye)
Istanbul, 34303, Turkey (Türkiye)
Dorest, BH7 7DW, United Kingdom