Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

Prior treatment

• 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
• 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
• Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy
• Treatment with strong or moderate CYP3A4 inhibitor or inducer

Other illness

• 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
• Type 1 diabetes mellitus
• 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

Other

• Systolic BP \< 90 mmHg, or symptomatic hypotension within the past 24 hours

• 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