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

Trial details

Who runs it

AstraZeneca

Trial code

NCT06307652EU 2023-508162-15-00

Record updated

13 October 2026

Original description

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.Read full original descriptionShow less

A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function

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.

Inclusion: 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: 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; 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; Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours.

ClinicalTrials.gov NCT06307652 · EU CTIS 2023-508162-15-00