Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Brigham and Women's Hospital
- Study ID
- NCT05030545
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Hypertension
- Primary Aldosteronism
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Eplerenone — DRUGAfter baseline cardiac imaging with PET and echocardiogram, participants will be treated with eplerenone for 6 months at a starting dose of 50mg daily and up to a maximally tolerated dose of 100mg daily, followed by repeat imaging with PET and echocardiogram.
Study Details
This research study aims to learn more about the impact the hormone aldosterone on the heart. Primary aldosteronism is a condition where the body's adrenal glands make too much of the hormone aldosterone, which can cause high blood pressure and increase the risk of heart and kidney disease. Treatment with medications that block aldosterone can reduce that risk. This study is trying to learn whether treatment with a medication that blocks aldosterone can improve heart function in people who make too much aldosterone.
Key Dates
- Start date
- Dec 15, 2022
- Status verified
- Feb 2025
- Primary completion
- Oct 31, 2026
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Eplerenone TreatmentEplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
Primary Outcome Measure
Change in myocardial flow reserve (MFR, unitless ratio) [ Time Frame: 6 months ]
Central Contacts
- Jenifer M Brown, MD8573071990
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Eva Abel 617-525-3803 |
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