Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function (BalanceD-HF)
Actively Recruiting
About This Study
This Phase III, randomized, double-blind, active-controlled trial evaluates the efficacy of balcinrenone/dapagliflozin compared to dapagliflozin monotherapy in patients with chronic heart failure and impaired kidney function (eGFR 20-60) who are not taking an MRA (spironolactone, eplerenone, finerenone). Participants are randomized 1:1:1 to receive either 15 mg/10 mg balcinrenone/dapagliflozin, 40 mg/10 mg balcinrenone/dapagliflozin, or 10 mg dapagliflozin once daily. The primary objective is to assess the impact of these interventions on the risk of cardiovascular death and heart failure events, including those with and without hospitalization. This event-driven study monitors outcomes over an estimated 20-month blinded treatment period.
Who Can Participate?
✓ Inclusion Criteria
- •Age ≥ 18 years
- •Documented diagnosis of symptomatic HF (NYHA functional class II-IV)
- •Having had a recent HF event within 6 months (hospitalization or urgent visit)
- •Have a LVEF value from an assessment within the last 12 months
- •Managed with SoC therapy for HF and renal impairment according to local guidelines
- •NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter)
- •Not taking an MRA
- •An eGFR ≥ 20 to < 60 mL/min/1.73 m2
- •Serum/plasma potassium ≤ 5.0 mmol/L
✗ Exclusion Criteria
- •Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period
- •Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations
- •History of hypertrophic obstructive cardiomyopathy
- •Complex congenital heart disease or severe uncorrected primary valvular disease
- •Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- •Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours
- •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
- •Type 1 diabetes mellitus
- •Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
- •Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy
- •Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks
- •Treatment with strong or moderate CYP3A4 inhibitor or inducer