Actively Recruiting
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Led by Brigham and Women's Hospital · Updated on 2025-02-07
40
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the hormone aldosterone affects the heart, especially in people with primary aldosteronism, a condition where the adrenal glands produce too much aldosterone. This hormone can cause high blood pressure and increase the risk of heart and kidney problems. The study aims to find out if blocking aldosterone with medication can improve heart function for those affected by this condition. Participants will receive treatment with eplerenone, a medication that blocks the mineralocorticoid receptor, for six months. Before starting treatment, cardiac imaging tests including a PET stress test and echocardiogram will be done to assess heart blood flow and structure. These tests will be repeated after the six-month treatment period to evaluate changes. The medication dose starts at 50 mg daily and may increase to 100 mg daily, depending on tolerance. During the study, participants will undergo heart imaging tests before and after treatment to measure blood flow and heart function changes. Researchers will track heart blood flow, heart muscle strain, and heart size using echocardiograms and PET scans. The main outcome is the change in myocardial flow reserve over six months. Safety evaluations and monitoring of kidney function and potassium levels will be conducted throughout the study. Participation lasts for at least six months of treatment and follow-up testing.
CONDITIONS
Brief Title
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 85 years
- Able to provide informed consent and willing to comply with the study
- Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter 70 cm; circumference 220 cm)
- Hypertension treated with at least one antihypertensive medication
- Cohort A: Clinically confirmed diagnosis of primary aldosteronism not yet treated with mineralocorticoid receptor antagonists
- Cohort B: Clinically indicated cardiac PET perfusion scan within preceding 3 months and echocardiogram within preceding 6 months
You will not qualify if you...
- History of heart attack, coronary artery bypass graft, known cardiomyopathy (ejection fraction less than 40%, hypertrophic cardiomyopathy, and/or amyloid), or cardiac transplantation
- Allergy or contraindication to eplerenone or spironolactone
- Current pregnancy or breastfeeding
- Estimated glomerular filtration rate less than 45 mL/min/1.73m2 or potassium level above 5.1 on recent labs
- Cohort A: Planned adrenalectomy within the next 6 months
- Cohort B: 10% or greater burden of ischemia on qualifying PET scan
- Cohort B: Planned coronary angiogram or revascularization within the next 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months
Participants receive eplerenone treatment for 6 months to assess its impact on heart blood flow and structure through cardiac PET stress tests and echocardiograms.
1 baseline visit and 1 follow-up visit after treatment
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
Jenifer M Brown, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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