A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation
- Conditions
- Heart Failure
- Registration Number
- NCT05636176
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5600
Inclusion Criteria:<br><br> - Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2<br> milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular<br><br> - At least one of the following:<br><br> 1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300<br> picograms per milliliter (pg/mL) at screening (Visit 1) for patients without<br> ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at<br> screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note<br> that the screening electrocardiogram (ECG) must be obtained the same day as<br> sampling for NT-proBNP.<br><br> 2. Hospitalisation or urgent/unplanned visit with a primary diagnosis of<br> decompensated heart failure which required intravenous loop diuretic treatment,<br> within the last 9 months prior to screening (visit 1) in combination with<br> NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients<br> without ongoing atrial fibrillation/flutter. If ongoing atrial<br> fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than<br> equal to 600 pg/mL.<br><br> - Diagnosis of heart failure (New York Heart Association [classification] [NYHA] Class<br> II-IV).<br><br> - Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented<br> by echocardiography within 12 months prior to or at screening (visit 1). The LVEF<br> must be documented in medical records and the most recent measurement must be used<br> to determine eligibility with no interim event signalling potential deterioration in<br> ejection fraction (e.g., myocardial infarction [MI] or heart failure [HF]<br> hospitalisation).<br><br> - Structural heart disease and/or functional heart disease documented by<br> echocardiography within 12 months prior to or at screening (visit 1) showing at<br> least one of the following:<br><br> - Left atrial (LA) volume index greater than 34 milliliter per meter square (mL/m^2).<br><br> - LA diameter greater than equal to 3.8 centimeter (cm).<br><br> - LA length greater than equal to 5.0 cm.<br><br> - LA area greater than equal to 20 cm square.<br><br> - LA volume greater than equal to 55 milliters (mL).<br><br> - Intraventricular septal thickness greater than equal to 1.1 cm.<br><br> - Posterior wall thickness greater than equal to 1.1 cm.<br><br> - Left ventricular (LV) mass index greater than equal to 115 grams per meter square<br> (g/m^2 ) in men or greater than equal to 95 g/m^2 in women.<br><br> - E/e' (mean septal and lateral) greater than equal to 10.<br><br> - e' (mean septal and lateral) less than 9 centimeter per second (cm/s).<br><br> - No heart failure hospitalisations or urgent heart failure visits between screening<br> (visit 1) and randomisation (visit 2).<br><br>Exclusion Criteria:<br><br>Medical conditions - cardiovascular<br><br> - Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack,<br> or heart failure hospitalisation, within 30 days prior to screening (visit 1).<br><br> - Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at<br> screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient<br> should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential<br> participants may be retested for this criterion within the visit window and without<br> rescreening, at the discretion of the investigator).<br><br> - Heart rate above 110 or below 40 beats per minute as evaluated on the<br> electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential<br> participants may be retested for this criterion within the visit window and without<br> rescreening, at the discretion of the investigator).<br><br> - Planned coronary, carotid or peripheral artery revascularisation known during the<br> screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).<br><br> - Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure<br> known during the screening period (visit 1).<br><br> - Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure<br> (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation<br> (visit 2) or any major surgical procedure planned at the time of randomisation<br> (visit 2).<br><br> - Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid),<br> arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic<br> hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis,<br> constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary<br> valve disease.<br><br> - Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease<br> including COPD.<br><br> - Any other condition judged by the investigator that could account for heart failure<br> symptoms and signs (e.g., anaemia, hypothyroidism).<br><br>Medical conditions - infections/immunosuppression<br><br> - Clinical evidence of, or suspicion of, active infection at the discretion of the<br> investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to First Occurrence of a Composite Heart Failure Endpoint Consisting of: Cardiovascular (CV) Death, Heart Failure (HF) Hospitalisation or Urgent HF Visit
- Secondary Outcome Measures
Name Time Method