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

NCT06677060
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
11,300
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Lead sponsor
AstraZeneca
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Start date
2025-03-14
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Number of sites
953
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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.
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Acronym
Prevent-HF
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Short title
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
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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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-12-17
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First posted
2024-11-06
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Registry last updated
2026-07-31
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Primary completion date
2029-12-17
clinicaltrials.gov
Start date
2025-03-14
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Participants
11,300
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Participant count basis
Estimated
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Planned participants
11,300
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Protocol amendments
2
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Number of sites
953
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06677060
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ClinicalTrials.gov ID
NCT06677060
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Registry record
Open registry record
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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
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • 2024-514506-32-00
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)