Do you suffer from Heart Failure and Inflammation?
This clinical research study is being conducted to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get 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 injections of study medicine and to fill in questionnaires.
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 (New York Heart Association [classification] [NYHA] Class II-IV).
- 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 milliliter per meter square (mL/m^2).
- LA diameter greater than equal to 3.8 centimeter (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 milliters (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).
- Have had no heart failure hospitalizations or urgent heart failure visits between screening (visit 1) and randomization (visit 2).
You may not qualify to participate if you:
- Have experienced 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 equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, you should be receiving greater than, or 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).
- Have a 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).
- Have any planned coronary, carotid or peripheral artery revascularization known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
- Have any planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
- Have had 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).
- Experience 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.
- Have any primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including 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.
