HERMES: Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Brief description of study
This study will determine if ziltivekimab, a monoclonal antibody, can be used to treat people living with heart failure and inflammation. Previous studies showed that ziltivekimab can lower inflammation, which may have a positive effect on heart failure symptoms. The HERMES study will look more into this effect. Also, the information collected during the study can help improve the understanding of:
- heart failure or related diseases
- how the study medicine works in the body
- how to improve the treatment of people with heart failure or related diseases.
Detailed description of study
Participants will be randomized (like flipping a coin) to receive either ziltivekimab or placebo. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their study drug injections and to fill in questionnaires.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Heart failure
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion
- ≥ 18 years of age
- Documented confirmed Heart Failure diagnosis
- Specific echocardiography (echo) criteria at screening (visit 1)
- Left ventricular ejection fraction (LVEF) greater than 40 percent (%) documented by echocardiography within 12 months prior to or at screening (visit 1)
Exclusion
- Heart attack, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization, within 30 days prior to screening (visit 1)
- Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1)
- Heart rate above 110 or below 40 beats per minute at screening (visit 1)
- Planned coronary, carotid or peripheral artery procedure 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 surgery (cardiac, non-cardiac, or endoscopy) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2)
