Study to evaluate the effect of balcinrenone/dapagliflozin in patients with heart failure and impaired kidney function - BalanceD-HF

Inclusion Criteria

• 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