Sherman Clinical Research | Sherman, TX
Status and phase
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About
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.
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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:
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
Primary purpose
Allocation
Interventional model
Masking
680 participants in 2 patient groups, including a placebo group
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Central trial contact
Novo Nordisk
Data sourced from clinicaltrials.gov
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