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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Eplerenone — DRUG
    After 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 Treatment
    Eplerenone (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

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Eva Abel
617-525-3803

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