Recruiting

Phase 3

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

Sponsor:

AstraZeneca

Code:

NCT06307652

Conditions

Heart Failure and Impaired Kidney Function

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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

dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin

Study Details

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.

Conditions

Heart Failure and Impaired Kidney Function

Study ID

NCT06307652

Start date

Apr 12, 2024

Status verified date

Jun, 2026

Completion date

Jun 11, 2027

Anticipated

Primary completion date

Jun 11, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: balcinrenone/dapagliflozin 15 mg/10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

experimental: balcinrenone/dapagliflozin 40 mg/10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

active comparator: dapagliflozin 10 mg

Patients will be randomized 1:1:1 to either combination of balcinrenone/dapagliflozin and matching placebo for dapagliflozin or dapagliflozin and matching placebo for balcinrenone/dapagliflozin

Interventions

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

Primary outcome measure

Time to first occurrence of any of the components of the composite of: •CV death •HF hospitalisation •HF event without hospitalisation [ Time Frame: Approximately 38 months ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

Locations

Research Site

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Alexander City, Alabama, United States, 35010

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Fairhope, Alabama, United States, 36532

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Huntsville, Alabama, United States, 35801

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Phoenix, Arizona, United States, 85016

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Phoenix, Arizona, United States, 85044

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Little Rock, Arkansas, United States, 72205

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Beverly Hills, California, United States, 90211

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Covina, California, United States, 91723

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Los Angeles, California, United States, 90073

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Los Angeles, California, United States, 90089

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Redding, California, United States, 96001

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San Diego, California, United States, 92123

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San Francisco, California, United States, 94110

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San Francisco, California, United States, 94121

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Vista, California, United States, 92081

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West Hills, California, United States, 91307

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Aurora, Colorado, United States, 80045

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Boca Raton, Florida, United States, 33486

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Bradenton, Florida, United States, 34209

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Delray Beach, Florida, United States, 33484

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Fort Lauderdale, Florida, United States, 33308

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Gainesville, Florida, United States, 32610

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Jacksonville, Florida, United States, 32209

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Miami, Florida, United States, 33176

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Miami Lakes, Florida, United States, 33014

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Palm Beach Gardens, Florida, United States, 33410

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Pensacola, Florida, United States, 32503

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Safety Harbor, Florida, United States, 34695

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Saint Augustine, Florida, United States, 32086

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St. Petersburg, Florida, United States, 33701

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Tampa, Florida, United States, 33617

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Atlanta, Georgia, United States, 30303

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Atlanta, Georgia, United States, 30309

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Peachtree City, Georgia, United States, 30269

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Tucker, Georgia, United States, 30084

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Chicago, Illinois, United States, 60637

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Hazel Crest, Illinois, United States, 60429

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Peoria, Illinois, United States, 61614

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Winfield, Illinois, United States, 60190

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Elkhart, Indiana, United States, 46514

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Evansville, Indiana, United States, 47710

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Hammond, Indiana, United States, 46324

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Muncie, Indiana, United States, 47303

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Munster, Indiana, United States, 46321

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Waterloo, Iowa, United States, 50701

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Wichita, Kansas, United States, 67226

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West Monroe, Louisiana, United States, 71291

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Rockville, Maryland, United States, 20850

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Boston, Massachusetts, United States, 02114

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Worcester, Massachusetts, United States, 01655

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Bloomfield Hills, Michigan, United States, 48304

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Flint, Michigan, United States, 48504

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Ypsilanti, Michigan, United States, 48197

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Saint Paul, Minnesota, United States, 55109

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Jackson, Mississippi, United States, 39216

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Columbia, Missouri, United States, 65201

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Kansas City, Missouri, United States, 64111

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Kansas City, Missouri, United States, 64128

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Lincoln, Nebraska, United States, 68506

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Lincoln, Nebraska, United States, 68510

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Henderson, Nevada, United States, 89074

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Jersey City, New Jersey, United States, 07302

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Somerset, New Jersey, United States, 08873

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Brooklyn, New York, United States, 11219

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Brooklyn, New York, United States, 11220

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Clifton Park, New York, United States, 12065

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New York, New York, United States, 10029

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Staten Island, New York, United States, 10310

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The Bronx, New York, United States, 10451

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The Bronx, New York, United States, 10455

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Asheville, North Carolina, United States, 28801

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Chapel Hill, North Carolina, United States, 27517

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Charlotte, North Carolina, United States, 28204

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Durham, North Carolina, United States, 27710

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Pinehurst, North Carolina, United States, 28374

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Wilmington, North Carolina, United States, 28401

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Cincinnati, Ohio, United States, 45219

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Cincinnati, Ohio, United States, 45267

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Springfield, Ohio, United States, 45504

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Portland, Oregon, United States, 97225

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Abington, Pennsylvania, United States, 19001

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Camp Hill, Pennsylvania, United States, 17011

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Hershey, Pennsylvania, United States, 17033

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Philadelphia, Pennsylvania, United States, 19104

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Providence, Rhode Island, United States, 02908

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Charleston, South Carolina, United States, 29401

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Charleston, South Carolina, United States, 29425

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Lancaster, South Carolina, United States, 29720

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Rapid City, South Dakota, United States, 57701

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Jackson, Tennessee, United States, 38305

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Knoxville, Tennessee, United States, 37916

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Memphis, Tennessee, United States, 38120

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Nashville, Tennessee, United States, 37212

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Tullahoma, Tennessee, United States, 37388

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Allen, Texas, United States, 75013

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Amarillo, Texas, United States, 79106

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Amarillo, Texas, United States, 79121

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Cypress, Texas, United States, 77429

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Dallas, Texas, United States, 75204

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Dallas, Texas, United States, 75216

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Dallas, Texas, United States, 75390

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El Paso, Texas, United States, 79905

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Houston, Texas, United States, 77025

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McKinney, Texas, United States, 75069

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McKinney, Texas, United States, 75071

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Odessa, Texas, United States, 79761

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San Antonio, Texas, United States, 78229

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Temple, Texas, United States, 76508

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Tyler, Texas, United States, 75701

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Tyler, Texas, United States, 75702

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Salt Lake City, Utah, United States, 84148

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Falls Church, Virginia, United States, 22042

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Newport News, Virginia, United States, 23606

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Winnipeg, Manitoba, Canada, R2H 2A6

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Sydney, Nova Scotia, Canada, B1P 1P3

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Cambridge, Ontario, Canada, N1R 7R1

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Hamilton, Ontario, Canada, L8L 5G4

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London, Ontario, Canada, N6A 5A5

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Newmarket, Ontario, Canada, L3Y 2P6

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North York, Ontario, Canada, M6B 3H7

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Thunder Bay, Ontario, Canada, P7B 7C7

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Toronto, Ontario, Canada, M6G 1M2

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Waterloo, Ontario, Canada, N2T 0C1

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Greenfield Park, Quebec, Canada, J4V 2H1

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Montreal, Quebec, Canada, H1T 1C8

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Montreal, Quebec, Canada, H2X 0C1

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Montreal, Quebec, Canada, H4J 1C5

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Saint-Charles-Borromée, Quebec, Canada, J6E 2B4

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Trois-Rivières, Quebec, Canada, G9A 4P3

More Information

Sponsor

AstraZeneca

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-06-26.