Do you suffer from Heart Failure and Inflammation?
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.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with heart failure, and whether it will be made widely available to all Canadians who struggle with this condition. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have a diagnosis of heart failure.
- Have no heart failure hospitalizations or urgent heart failure visits between screening and randomization.
- Are able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 meters.
You may not qualify to participate if you:
- Experience myocardial infarction, stroke, unstable angina pectoris, transient ischemic attack, or heart failure hospitalization within 30 days prior to screening (visit 1).
- Have 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.
- Have a heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1).
- Have a planned coronary, carotid or peripheral artery revascularization known during the screening period (visit 1).
- Have a planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
- Have a major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomization (visit 2) or any major surgical procedure planned at the time of randomization (visit 2).
- Have primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD).
- Have any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anemia, hypothyroidism).
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.