Baxdrostat and Ventricular Remodeling

Sponsor
Subodh Verma
Study ID
NCT07655362
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Cardiac Remodeling

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Baxdrostat — DRUG
    Participants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care.
  • Placebo — DRUG
    Participants will take placebo once daily (orally), in addition to standard-of-care.

Study Details

The goal of this trial is to learn whether adding the blood pressure medication baxdrostat (Baxfendy) to standard-of-care medical therapies will beneficially change the heart structure and function of adults who have high blood pressure, thickened left heart walls, and are at risk for heart or kidney disease. To determine if baxdrostat improves heart structure and function, the participants will: * take a baxdrostat or a placebo (a look-alike tablet that contains no drug) tablet once a day for 12 months * undergo a safe and non-invasive cardiac magnetic resonance imaging scan (to measure heart mass, stiffness and function) at the beginning of the study and 12 months later * visit the clinic for checkups and blood or urine tests 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months after taking the first tablet

Key Dates

First listed
Jun 17, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
286 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Baxdrostat
    Active treatment group
  • Placebo Comparator: Placebo
    Control treatment group

Primary Outcome Measure

Left Ventricular Mass indexed to baseline body surface area (LVMi) [ Time Frame: 12 months ]

Central Contacts