RecruitingPhase 4NCT05030545

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

Sponsor

Brigham and Women's Hospital

Enrollment

40 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Hypertension Primary Aldosteronism

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This pilot study looks at how too much aldosterone (a hormone that affects blood pressure and salt balance) affects the heart over time. It uses specialized PET/CT heart imaging and other tests to compare patients with confirmed primary aldosteronism (a treatable hormonal condition) against those with possible undiagnosed cases. **You may be eligible if...** - You are 18–85 years old - You have high blood pressure being treated with at least one medication - You have a confirmed diagnosis of primary aldosteronism not yet treated with mineralocorticoid receptor blockers (Cohort A), OR - You have high blood pressure and possible but undiagnosed aldosteronism (Cohort B) - You fit safely in a PET/CT scanner **You may NOT be eligible if...** - You have had a heart attack, bypass surgery, known heart muscle disease, or a heart transplant - You are allergic to eplerenone or spironolactone (the study drugs) - You are pregnant or breastfeeding - Your kidney function is significantly reduced or your potassium is high Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEplerenone

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.