Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-06-24 @ 10:09 AM
Study NCT ID:
NCT06677060
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo controlled'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2024-11-05', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine if baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of an HF event or CV death', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* Hospitalisation for HF\n* HF without hospitalisation\n* CV death'}], 'secondaryOutcomes': [{'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of hospitalisation for HF or CV death', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* Hospitalisation for HF\n* CV death'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* Hospitalisation for HF\n* HF without hospitalisation'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to CV death'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of all-cause mortality', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to all-cause death'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of stroke or CV death', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* Stroke\n* CV death'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of atrial fibrillation or CV death in participants without history of atrial fibrillation at baseline', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* New diagnosis of atrial fibrillation\n* CV death'}, {'measure': 'To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MI or CV death', 'timeFrame': 'Event driven; Up to 38 months', 'description': 'Time to first occurrence of any of the components of the composite of:\n\n* MI\n* CV death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure: Baxdrostat; Dapagliflozin; cardiovascular'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '40913594', 'type': 'DERIVED', 'citation': 'Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nUpon 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.\n\nSite visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.\n\nThe 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.\n2. Diagnosed with T2DM and requiring treatment\n3. Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)\n4. History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.\n5. Central laboratory serum potassium must meet the following criteria at the Screening\n\n Visit, based on screening eGFR:\n * for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be\n\n ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit\n * for participants with screening eGFR \\< 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit\n6. At least one additional risk factor for HF:\n\n * Age ≥ 70 years\n * UACR \\> 20 mg/g\n * eGFR \\< 60 mL/min/1.73 m2\n * History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)\n * History of atrial fibrillation or atrial flutter\n * NT-proBNP \\> 125 ng/L\n\nExclusion Criteria:\n\n1. Previously confirmed diagnosis and treatment of heart failure\n2. An eGFR \\< 30 mL/min/1.73 m2 at screening\n3. Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening\n4. Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol/mol) at screening\n5. Serum sodium \\< 135 mmol/L at screening, determined as per central laboratory assessment\n6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation\n7. Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation\n8. Percutaneous coronary intervention within 1 month prior to randomisation\n9. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history\n10. Documented history of adrenal insufficiency\n11. Any dialysis (including for acute kidney injury) within 3 months prior to screening\n12. Any acute kidney injury within 3 months prior to screening\n13. History or known allergy/hypersensitivity to the study treatment, as judged by the Investigator (eg, SGLT2i or active substance or excipients)\n14. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant)\n15. Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to screening)\n16. Drug or alcohol abuse that in the Investigator's judgement makes the participant a poor candidate for the study\n17. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone) or aldosterone synthase inhibitor within 4 weeks prior to screening and/or during the study\n18. Concomitant therapy with strong inducers of cytochrome P450\n19. Use of potassium-sparing diuretics (such as triamterene or amiloride) and direct renin inhibitor (eg, aliskiren) at the time of screening\n20. Use of potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening"}, 'identificationModule': {'nctId': 'NCT06677060', 'acronym': 'Prevent-HF', 'briefTitle': 'Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death', 'orgStudyIdInfo': {'id': 'D6973C00001'}, 'secondaryIdInfos': [{'id': '2024-514506-32-00', 'type': 'REGISTRY', 'domain': 'EU CT number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baxdrostat/Dapagliflozin', 'description': '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.', 'interventionNames': ['Drug: Baxdrostat and dapagliflozin']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/Dapagliflozin', 'description': 'Patients will receive a dose of dapagliflozin in combination with matching placebo', 'interventionNames': ['Other: Placebo and dapagliflozin']}], 'interventions': [{'name': 'Baxdrostat and dapagliflozin', 'type': 'DRUG', 'otherNames': ['Baxdrostat CIN-107'], 'description': 'baxdrostat tablet and dapagliflozin tablet', 'armGroupLabels': ['Baxdrostat/Dapagliflozin']}, {'name': 'Placebo and dapagliflozin', 'type': 'OTHER', 'description': 'placebo tablet and dapagliflozin tablet', 'armGroupLabels': ['Placebo/Dapagliflozin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, 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