Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Novo Nordisk A/S
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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: 1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the sam…
Interventions
- DrugZiltivekimab
Ziltivekimab subcutaneous (s.c.) injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
- DrugPlacebo
Ziltivekimab placebo s.c. injection in a pre-filled syringe or a pen-injector once-monthly for up to 4 years.
Locations (1117)
- Advanced Cardiovascular, LLCAlexander City, Alabama
- Eastern Shore Rsrch Inst, LLCFairhope, Alabama
- Heart Center Rsrch_HunstvilleHuntsville, Alabama
- Banner University Medical CtrPhoenix, Arizona
- Banner University Medical CtrPhoenix, Arizona
- Cardiology & Medicine ClinicLittle Rock, Arkansas