Do you suffer from Heart Failure and Renal Impairment?
The purpose of this study is to investigate the effect of balcinrenone/dapagliflozin compared with dapagliflozin, on the risk of CV death, HF event with and without hospitalisation, in patients with chronic HF, impaired kidney function, and who have had a recent HF event.
Eligible patients will randomly be assigned with a 1:1:1 ratio to receive once daily administration of one capsule and one tablet of one of the following treatments:
- Balcinrenone/dapagliflozin 15 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
- Balcinrenone/dapagliflozin 40 mg/10 mg capsule and matching placebo for dapagliflozin 10 mg tablet
- Dapagliflozin 10 mg tablet and matching placebo for balcinrenone/dapagliflozin capsule
The study is event driven, and the average study duration for a participant is estimated to be 22 months including screening period, 20 months blinded treatment period and a one-month follow-up period on open-label dapagliflozin.
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:
- Are 18 years of age or older
- Have a documented diagnosis of symptomatic heart failure
- Have had a recent heart failure event within 6 months (hospitalization or urgent visit)
- Have a LVEF value from an assessment within the last 12 months
- Have managed your condition with SoC therapy for heart failure and renal impairment according to local guidelines
You may not qualify to participate if you:
- Have experienced acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months
- Have had major cardiac surgery, coronary revascularization or valvular repair or replacement, or implantation of a Cardiac resynchronization therapy device within 3 months prior to enrolment or planned to undergo any of these operations
- Have a history of hypertrophic obstructive cardiomyopathy
- Have complex congenital heart disease or severe uncorrected primary valvular disease
- Have symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- Have systolic BP < 100 mmHg, or symptomatic hypotension within the past 24 hours
- Have primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment
- Have type 1 diabetes mellitus
- Have had kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- Have hepatic disease, including active HBV or HCV infection, or other cause of hepatitis, and/or hepatic impairment (Child-Pugh class A-C), AST or ALT >3 × ULN; or TBL > 2 × ULN at time of screening
- Have a suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- Are treatmed with strong or moderate CYP3A4 inhibitor or induce
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.