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Research Study for Heart Failure and Inflammation

This study is looking at whether ziltivekimab can help people with heart failure and inflammation. You might be able to join if you have heart failure and certain levels of inflammation markers in your blood, specifically high-sensitivity C-reactive protein (hs-CRP) and N-terminal-pro-brain natriuretic peptide (NT-proBNP). Participants will either receive ziltivekimab or a placebo (an inactive substance that looks like the study medicine) once a month, given as a shot under the skin. The study will measure how ziltivekimab affects your heart failure symptoms using a questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) over 12 months. The study aims to enroll 680 people and is expected to last up to 1 year and 4 months.

Study design
This is an interventional study where participants are randomly assigned to receive either ziltivekimab or a placebo. The study plans to include 680 participants.
What's involved
You would receive monthly subcutaneous (under the skin) injections of either ziltivekimab or placebo. The study is expected to last up to 1 year and 4 months.
Compensation
Not stated in the trial record.
Follow-up
Your heart failure symptoms will be monitored from the start of the study until the end of treatment, which is at month 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06200207

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

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Novo Nordisk A/S
~680 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:ZiltivekimabPlacebo

At a glance

Recruiting sites
0 of 217 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
Measured over From randomisation (month 0) to end-of-treatment (month 12)

Conditions

Heart Failure
Systemic Inflammation

Explore related trials

Heart FailureSystemic autoinflammationC reactive proteinN-Terminal Fragment Brain Natriuretic Protein

Where it's being run

217 sites across 72 states
Greece18
Turkey (Türkiye)13
Germany10
Bulgaria9
Texas8
Argentina8
Czechia8
Poland8

Study leadership

  • Clinical Transparency dept. 2834 · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)From randomisation (month 0) to end-of-treatment (month 12)

    Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.