Baxdrostat and Ventricular Remodeling
NCT07655362 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286
Last updated 2026-06-17
Summary
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
Conditions
- Cardiac Remodeling
Interventions
- DRUG
-
Baxdrostat
Participants will take 2mg baxdrostat (Baxfendy) once daily (orally), in addition to standard-of-care.
- DRUG
-
Participants will take placebo once daily (orally), in addition to standard-of-care.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Subodh Verma
lead OTHER
Principal Investigators
-
Subodh Verma, MD, PhD · North York Diagnostic and Cardiac Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-06-30
- Completion
- 2028-12-31
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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