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

ConditionsHeart Failure Systemic Inflammation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorNovo Nordisk A/S

About this trial

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

Qualifiers

Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

Ziltivekimab
Placebo

Treatment groups

680 Participants

are divided into 2 treatment groups

Locations

240

Argentina

Cardiología PalermoC1425, City of Buenos AiresBuenos Aires, Argentina

Centro Médico CIMELB1824KAJ, Lanús EsteBuenos Aires, Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica ApliC1425AGC, Buenos Aires Argentina

CIPREC PueyrredonC1119ACN, Buenos Aires Argentina

Sponsors and collaborators

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov