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

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 oratrial flutter)

• Not taking an MRA

• An eGFR ≥ 20 to < 60 mL/min/1.73 m2

• Serum/plasma potassium ≥ 3.5 mmol/L and ≤ 5.0 mmol/L

Exclusion Criteria:

• Acute coronary syndrome (unstable angina or myocardial infarction), stroke ortransient ischaemic attack within the previous 3 months

• Major cardiac surgery, coronary revascularisation or valvular repair or replacement,or implantation of a Cardiac resynchronisation therapy device within 3 months priorto enrolment 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 < 100 mmHg, or symptomatic hypotension within the past 24 hours

• Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary diseaseincluding COPD or exacerbation of COPD requiring invasive mechanical ventilationassistance within 12 months prior to enrolment

• Type 1 diabetes mellitus

• Kidney replacement therapy in the past 4 weeks, currently requiring kidneyreplacement or imminent plan to start kidney replacement therapy

• 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

• Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisationfor COVID-19 within the last 12 weeks

• Treatment with strong or moderate CYP3A4 inhibitor or inducer