> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-iii-study-investigating-heart-failure-and-d84ff84b-476e-4c74-a7e8-4d2f0f3afa23 > Record changed: 2026-10-13 # Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin NCT06677060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Participants 11,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Start date 2025-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) Number of sites 953 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Acronym** Prevent-HF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Short title** Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Dates **Completion date** 2029-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **First posted** 2024-11-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Primary completion date** 2029-12-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Start date** 2025-03-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Size and sites **Participants** 11,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Planned participants** 11,300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Number of sites** 953 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Identifiers **Registry ID** NCT06677060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **ClinicalTrials.gov ID** NCT06677060 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masking description** Placebo controlled **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Outcomes ### Primary outcomes 1. 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 Time to first occurrence of any of the components of the composite of: \* Hospitalisation for HF \* HF without hospitalisation \* CV death ### Secondary outcomes 1. 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 Time to first occurrence of any of the components of the composite of: \* Hospitalisation for HF \* CV death 2. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of HF events Timeframe: Event driven; Up to 38 months Time to first occurrence of any of the components of the composite of: \* Hospitalisation for HF \* HF without hospitalisation 3. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of CV death Timeframe: Event driven; Up to 38 months Time to CV death 4. 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 Time to all-cause death 5. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of 4-point MACE (CV death, MI, stroke, and hospitalisation for HF) Timeframe: Event driven; Up to 38 months Time to first occurrence of any of the components of the composite of: \* CV death \* MI \* Stroke \* Hospitalisation for HF Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Sites - Research SiteBirmingham, United StatesRecruiting - Research SiteCentreville, United StatesRecruiting - Research SiteFairhope, United StatesRecruiting - Research SiteHuntsville, United StatesRecruiting - Research SiteMobile, United StatesRecruiting - Research SiteSheffield, United StatesRecruiting - Research SiteVestavia Hills, United StatesRecruiting - Research SiteAnchorage, United StatesNot yet recruiting - Research SiteGilbert, United StatesRecruiting - Research SiteGlendale, United StatesRecruiting - Research SiteTempe, United StatesRecruiting - Research SiteTucson, United StatesRecruiting - Research SiteDublin, United StatesWithdrawn - Research SiteHuntington Beach, United StatesRecruiting - Research SiteInglewood, United StatesRecruiting - Research SiteLa Jolla, United StatesRecruiting - Research SiteLakewood, United StatesWithdrawn - Research SiteLincoln, United StatesRecruiting - Research SiteLoma Linda, United StatesRecruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteLos Angeles, United StatesNot yet recruiting - Research SiteSacramento, United StatesRecruiting - Research SiteSan Diego, United StatesRecruiting - Research SiteSan Dimas, United StatesRecruiting - Research SiteSan Francisco, United StatesRecruiting And 928 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## References - PubMed 40913594 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40913594/) Related publication ### Other registry identifiers - 2024-514506-32-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06677060) ## Related records ### Drugs (2) - [Baxdrostat](https://trialight.com/data/asset/baxdrostat-a2e43871-8326-4540-9aa3-5a6511c12d97.md) - [Dapagliflozin](https://trialight.com/data/asset/dapagliflozin-894f296e-52de-4036-ac69-f399eea07356.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (1) - [Heart failure](https://trialight.com/data/condition/heart-failure-e230b1c3-ce91-5f80-b80f-81fc353ce5cc.md) Primary condition ### Targets (1) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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