Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Trial Parameters
Brief Summary
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Eligibility 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 operatio