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Clinical Trials in the UK / NCT06307652
Recruiting Phase 3

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

NCT06307652 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2024-04-12
Last updated
2026-09-11

Condition(s) studied

Heart Failure and Impaired Kidney Function

Investigational drug(s) / intervention(s)

balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mgbalcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mgdapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (852)

FacilityCityRegionStatus
Research Site Alexander City Alabama Recruiting
Research Site Birmingham Alabama Withdrawn
Research Site Fairhope Alabama Recruiting
Research Site Huntsville Alabama Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Phoenix Arizona Recruiting
Research Site Little Rock Arkansas Recruiting
Research Site Beverly Hills California Recruiting
Research Site Covina California Recruiting
Research Site Encinitas California Terminated
Research Site Los Angeles California Recruiting
Research Site Los Angeles California Recruiting
Research Site Newport Beach California Terminated
Research Site Orange California Withdrawn
Research Site Redding California Recruiting
Research Site San Diego California Recruiting
Research Site San Francisco California Recruiting
Research Site San Francisco California Terminated
Research Site Santa Ana California Withdrawn
Research Site Thousand Oaks California Terminated
Research Site Vista California Recruiting
Research Site West Hills California Recruiting
Research Site Aurora Colorado Recruiting
Research Site Wheat Ridge Colorado Terminated
Research Site Altamonte Springs Florida Terminated
Research Site Boca Raton Florida Recruiting
Research Site Bradenton Florida Recruiting
Research Site Clearwater Florida Withdrawn
Research Site Delray Beach Florida Recruiting
Research Site Fort Lauderdale Florida Recruiting
Research Site Gainesville Florida Recruiting
Research Site Jacksonville Florida Recruiting
Research Site Miami Florida Terminated
Research Site Miami Florida Recruiting
Research Site Miami Lakes Florida Recruiting
Research Site Palm Beach Gardens Florida Recruiting
Research Site Pensacola Florida Recruiting
Research Site Port Charlotte Florida Withdrawn
Research Site Safety Harbor Florida Recruiting
Research Site Saint Augustine Florida Recruiting

+ 812 more sites — see the full list on the official registry below.

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06307652 on ClinicalTrials.gov ↗ ← All trials in the UK