A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (NCT06200207)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (13 items).
Location: Advanced Cardiovascular, LLC — Alexander City, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (217 Sites)
- Advanced Cardiovascular, LLC — Alexander City, Alabama
- Eastern Shore Rsrch Inst, LLC — Fairhope, Alabama
- Cardiology & Medicine Clinic — Little Rock, Arkansas
- Valley Clinical Trials, Inc. — Northridge, California
- UCI Health — Orange, California
- South California Heart Spc — Pasadena, California
- Clearwater Cardiovascular Consultants — Largo, Florida
- Ocala Cardiovascular Research — Ocala, Florida
- Ormond Beach Clinical Research — Ormond Beach, Florida
- St Johns Ctr Clin Rsch-St. Aug — Saint Augustine, Florida
- GA Arrhythmia Cons & Rsch Inst — Macon, Georgia
- Velocity Clin Rsrch - Savannah — Savannah, Georgia
- Chicago Medical Research LLC — Hazel Crest, Illinois
- UofL Health Care Outpatient — Louisville, Kentucky
- Maryland Cardiovascular Specialists - Baltimore — Baltimore, Maryland
- MD Medical Research — Oxon Hill, Maryland
- Cardio and Vascular Assoc-CAVA — Bloomfield Hills, Michigan
- Millennium Cardiology — Farmington Hills, Michigan
- Kansas City VA Medical Center — Kansas City, Missouri
- Washington University — St Louis, Missouri
- Renown Regional Medical Center — Reno, Nevada
- Long Island Cardiovascular Consultants PC — Lake Success, New York
- Mount Sinai Hosp at NYC — New York, New York
- Northwell Health Phys Cardio — Riverhead, New York
- University Of North Carolina At Chapel Hill — Chapel Hill, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.