Recruiting

Phase 3

Baxdrostat & DapagliflozinPhase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin

Sponsor:

AstraZeneca

Code:

NCT06677060

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Baxdrostat and dapagliflozin

Placebo and dapagliflozin

Study Details

Brief summary:

Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.

The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.

Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.

Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.

The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.

In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.

Conditions

Heart Failure

Study ID

NCT06677060

Start date

Mar 14, 2025

Status verified date

Jul, 2026

Completion date

Dec 17, 2029

Anticipated

Primary completion date

Dec 17, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.
Diagnosed with T2DM and requiring treatment
Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)
History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.
At least one additional risk factor for HF:

Age ≥ 70 years
UACR > 20 mg/g
eGFR < 60 mL/min/1.73 m2
History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)
History of atrial fibrillation or atrial flutter
NT-proBNP > 125 ng/L

Exclusion Criteria:

Previously confirmed diagnosis and treatment of heart failure
An eGFR < 30 mL/min/1.73 m2 at screening
Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening
Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) at screening
Serum sodium < 135 mmol/L at screening, determined as per central laboratory assessment
Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation
Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation
Percutaneous coronary intervention within 1 month prior to randomisation
Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history
Documented history of adrenal insufficiency
Any dialysis (including for acute kidney injury) within 3 months prior to screening
Any acute kidney injury within 3 months prior to screening
Prohibited concomitant medications

Study Design

Enrollment

11300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Baxdrostat/Dapagliflozin

Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

experimental: Placebo/Dapagliflozin

Patients will receive a dose of dapagliflozin in combination with matching placebo

Interventions

Baxdrostat and dapagliflozin

baxdrostat tablet and dapagliflozin tablet

Placebo and dapagliflozin

placebo tablet and dapagliflozin tablet

Primary outcome measure

To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death [ Time Frame: Event driven; Up to 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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Birmingham, Alabama, United States, 35205

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Centreville, Alabama, United States, 35042

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Fairhope, Alabama, United States, 36532

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Huntsville, Alabama, United States, 35801

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Mobile, Alabama, United States, 36608

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Sheffield, Alabama, United States, 35660

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Vestavia Hills, Alabama, United States, 35216

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Gilbert, Arizona, United States, 85296

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Glendale, Arizona, United States, 85308

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Tempe, Arizona, United States, 85283

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Tucson, Arizona, United States, 85712

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Huntington Beach, California, United States, 92648

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Inglewood, California, United States, 90301

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La Jolla, California, United States, 92037

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Lincoln, California, United States, 95648

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Loma Linda, California, United States, 92357

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Los Angeles, California, United States, 90035

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Sacramento, California, United States, 95841

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San Diego, California, United States, 92120

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San Dimas, California, United States, 91773

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San Francisco, California, United States, 94115

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Santa Maria, California, United States, 93454

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Thousand Oaks, California, United States, 91360

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Aurora, Colorado, United States, 80012

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Englewood, Colorado, United States, 80110

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Bridgeport, Connecticut, United States, 06606

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Stamford, Connecticut, United States, 06905

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Waterbury, Connecticut, United States, 06708

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Crystal River, Florida, United States, 34429

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Fort Myers, Florida, United States, 33912

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Jacksonville, Florida, United States, 32216

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Lakeland, Florida, United States, 33813

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Miami, Florida, United States, 33125

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Miami, Florida, United States, 33135

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Miami, Florida, United States, 33173

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Miami Lakes, Florida, United States, 33016

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Ocoee, Florida, United States, 34761

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Orlando, Florida, United States, 32822

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Palmetto Bay, Florida, United States, 33157

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Saint Augustine, Florida, United States, 32086

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Albany, Georgia, United States, 31707

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Atlanta, Georgia, United States, 30303

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Canton, Georgia, United States, 30114

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Columbus, Georgia, United States, 31904

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Cordele, Georgia, United States, 31015

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Suwanee, Georgia, United States, 30024

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Woodstock, Georgia, United States, 30189

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Idaho Falls, Idaho, United States, 83404

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Champaign, Illinois, United States, 61822

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Chicago, Illinois, United States, 60616

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Chicago, Illinois, United States, 60621

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Chicago, Illinois, United States, 60631

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Gurnee, Illinois, United States, 60031

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Island Lake, Illinois, United States, 60042

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Park Ridge, Illinois, United States, 60068

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Indianapolis, Indiana, United States, 46202

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Munster, Indiana, United States, 46321

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Richmond, Indiana, United States, 47374

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South Bend, Indiana, United States, 46617

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El Dorado, Kansas, United States, 67042

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Lenexa, Kansas, United States, 66219

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Newton, Kansas, United States, 67114

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Lexington, Kentucky, United States, 40509

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Owensboro, Kentucky, United States, 42301

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Paducah, Kentucky, United States, 42001

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Alexandria, Louisiana, United States, 71303

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Shreveport, Louisiana, United States, 71101

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Baltimore, Maryland, United States, 21229

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Beltsville, Maryland, United States, 20705

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Lutherville-Timonium, Maryland, United States, 21093

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Potomac, Maryland, United States, 20854

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Boston, Massachusetts, United States, 02115

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New Bedford, Massachusetts, United States, 02740

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Roslindale, Massachusetts, United States, 02131

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Farmington Hills, Michigan, United States, 48336

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Flint, Michigan, United States, 48532

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Troy, Michigan, United States, 48098

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Ypsilanti, Michigan, United States, 48197

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Mankato, Minnesota, United States, 56001

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Minneapolis, Minnesota, United States, 55417

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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, 64151

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St Louis, Missouri, United States, 63136

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Missoula, Montana, United States, 59804

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Norfolk, Nebraska, United States, 68701

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Omaha, Nebraska, United States, 68134

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Carson City, Nevada, United States, 89706

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Pennington, New Jersey, United States, 08534

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Somerset, New Jersey, United States, 08873

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Albuquerque, New Mexico, United States, 87102

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Albuquerque, New Mexico, United States, 87108

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Albany, New York, United States, 12208

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Brooklyn, New York, United States, 11201

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Brooklyn, New York, United States, 11220

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Massapequa, New York, United States, 11758

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New York, New York, United States, 10029

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Queens Village, New York, United States, 11428

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Charlotte, North Carolina, United States, 28287

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Durham, North Carolina, United States, 27701

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Fayetteville, North Carolina, United States, 28304

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Monroe, North Carolina, United States, 28112

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New Bern, North Carolina, United States, 28562

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Raleigh, North Carolina, United States, 27607

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Rocky Mount, North Carolina, United States, 27804

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Fargo, North Dakota, United States, 58104

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Beavercreek, Ohio, United States, 45431

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Canton, Ohio, United States, 44718

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Cincinnati, Ohio, United States, 45219

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Cincinnati, Ohio, United States, 45220

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Columbus, Ohio, United States, 43215

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Maumee, Ohio, United States, 43537

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Oklahoma City, Oklahoma, United States, 73111

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Oklahoma City, Oklahoma, United States, 73120

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Camp Hill, Pennsylvania, United States, 17011

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Horsham, Pennsylvania, United States, 19044

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Philadelphia, Pennsylvania, United States, 19114

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Scottdale, Pennsylvania, United States, 15683

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Smithfield, Pennsylvania, United States, 15478

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West Chester, Pennsylvania, United States, 19380

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Columbia, South Carolina, United States, 29209

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Fort Mill, South Carolina, United States, 29715

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Mt. Pleasant, South Carolina, United States, 29464

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North Charleston, South Carolina, United States, 29405

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Spartanburg, South Carolina, United States, 29301

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Cleveland, Tennessee, United States, 37312

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Morristown, Tennessee, United States, 37813

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Nashville, Tennessee, United States, 37203

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Austin, Texas, United States, 78704

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Beaumont, Texas, United States, 77702

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Brownsville, Texas, United States, 78526

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Dallas, Texas, United States, 75390-9015

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Duncanville, Texas, United States, 75137

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Houston, Texas, United States, 77084

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Houston, Texas, United States, 77089

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McAllen, Texas, United States, 78501

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McAllen, Texas, United States, 78503

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Mesquite, Texas, United States, 75149

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Paris, Texas, United States, 75462

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San Antonio, Texas, United States, 78257

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Stephenville, Texas, United States, 76401

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Sugar Land, Texas, United States, 77479

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Tomball, Texas, United States, 77375

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Weslaco, Texas, United States, 78596

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Woodway, Texas, United States, 76712

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Clearfield, Utah, United States, 84015

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Ogden, Utah, United States, 84405

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Burlington, Vermont, United States, 05401

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Burke, Virginia, United States, 22015

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Charlottesville, Virginia, United States, 22911

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Falls Church, Virginia, United States, 22042

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Manassas, Virginia, United States, 20110

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Midlothian, Virginia, United States, 23112

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Norfolk, Virginia, United States, 23502

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Norfolk, Virginia, United States, 23504

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Salem, Virginia, United States, 24153

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Redmond, Washington, United States, 98052

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Renton, Washington, United States, 98057

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Kingwood, West Virginia, United States, 26537

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Morgantown, West Virginia, United States, 26505

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Calgary, Alberta, Canada, T2H 2G4

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Calgary, Alberta, Canada, T2V 4J2

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Sherwood Park, Alberta, Canada, T8H 0N2

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Abbotsford British Columbia, British Columbia, Canada, V2S 0C2

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Moncton, New Brunswick, Canada, E1C 2Z3

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Saint John, New Brunswick, Canada, E2L 4L2

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St. John's, Newfoundland and Labrador, Canada, A1B 3V6

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Halifax, Nova Scotia, Canada, B3H 1V7

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Sydney, Nova Scotia, Canada, B1P 1P3

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Guelph, Ontario, Canada, N1H 1B1

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Hamilton, Ontario, Canada, L8J 0B6

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Hamilton, Ontario, Canada, L8L 5G4

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Markham, Ontario, Canada, L3S 0A2

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Newmarket, Ontario, Canada, L3Y 2P6

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North York, Ontario, Canada, M6B 3H7

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Oakville, Ontario, Canada, L6K 3W7

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Ottawa, Ontario, Canada, K2J 0V2

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Sarnia, Ontario, Canada, N7T 4X3

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Scarborough Village, Ontario, Canada, M1B 4Z8

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Toronto, Ontario, Canada, M4G 3E8

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Toronto, Ontario, Canada, M5B 1W8

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Toronto, Ontario, Canada, M6G 1M2

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Laval, Quebec, Canada, H7T 2P5

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Lévis, Quebec, Canada, G6V 9H4

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Mirabel, Quebec, Canada, J7J 2K8

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Montreal, Quebec, Canada, H1T 1C8

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Montreal, Quebec, Canada, H4A 3T2

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Québec, Quebec, Canada, G1G 5X1

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Québec, Quebec, Canada, G1V 4G5

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Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

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Sherbrooke, Quebec, Canada, J1H 5N4

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Terrebonne, Quebec, Canada, J6X 4P7

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Trois-Rivières, Quebec, Canada, G9A 4P3

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Regina, Saskatchewan, Canada, S4P 0W5

More Information

Sponsor

AstraZeneca

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

Heart failure: Baxdrostat; Dapagliflozin; cardiovascular

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 2026-07-31.