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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg

1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

DRUG

balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg

1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use

DRUG

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use

Locations (20)

Research Site
Alexander City, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Fairhope, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Beverly Hills, California, United States
Research Site
Covina, California, United States
Research Site
Encinitas, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
Orange, California, United States
Research Site
Redding, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
San Francisco, California, United States
Research Site
Santa Ana, California, United States
Research Site
Thousand Oaks, California, United States