RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Brigham and Women's Hospital • ClinicalTrials.gov ID: NCT05030545

Registry updated: 2026-10-15

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Description

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.

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.

Eligibility criteria

Cohort A: Overt \& Diagnosed PA Inclusion Criteria: * Adults aged 18-85 * 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 and circumference of PET/CT scanner are 70 cm and 220 cm, respectively) * Hypertension treated with at least one antihypertensive drug * Cohort A: Clinically confirmed diagnosis of PA not yet treated with mineralocorticoid receptor antagonists Exclusion Criteria: * History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation * Contraindication or allergy to eplerenone or spironolactone * Current pregnancy or breastfeeding * eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months * Cohort A: Planned adrenalectomy in the subsequent 6 months Cohort B: Subclinical \& Undiagnosed PA Inclusion Criteria: * Adults aged 18-85 * 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 and circumference of PET/CT scanner are 70 cm and 220 cm, respectively) * Hypertension treated with at least one antihypertensive drug * Cohort B: Clinically indicated cardiac PET perfusion scan within the preceding 3 months and echocardiogram within the preceding 6 months Exclusion Criteria: * History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation * Contraindication or allergy to eplerenone or spironolactone * Current pregnancy or breastfeeding * eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months * Cohort B: 10% or greater burden of ischemia on qualifying PET * Cohort B: Planned coronary angiogram/revascularization in the subsequent 6 months.

Conditions

Primary Aldosteronism Hypertension

Locations

Brigham and Women's Hospital — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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