NCT05636176
A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
Terminated
PHASE3Ages 18+InterventionalTreatmentNovo Nordisk A/S
~4,899 participants
Updated 2026-09-10 on ClinicalTrials.gov
What's tested:ZiltivekimabPlacebo
At a glance
Recruiting sites
0 of 1013 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit
Measured over From randomisation (month 0) to end of study (up to 48 months)
Conditions
NCT05636176
Where you'd take part
This study runs at 1013 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
'G. Gennimatas' General Hospital of Athens - Cardiology Department
Athens, Greeceno site contact published
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, Greeceno site contact published
'Medical Center Hipokrena' EOOD
Sevlievo, Bulgariano site contact published
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, Greeceno site contact published
"Carol Davila" Military Emergency Hospital
Bucharest, Romaniano site contact published
"Hygeia" General Hospital of Athens
Athens, Greeceno site contact published
"Hygeia" General Hospital of Athens
Athens, Greeceno site contact published
"MHAT - UniHospital" OOD
Panagyurishte, Bulgariano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
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
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Eligibility criteria
Inclusion
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 milliliters per meter square (mL/m\^2).
LA diameter greater than equal to 3.8 centimeters (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 milliliters (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
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 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 equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
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 COPD.
Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).
What this trial measures
- Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF VisitFrom randomisation (month 0) to end of study (up to 48 months)
Measured in months.