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

NCT05030545 · Brigham and Women's Hospital

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study

The study evaluates the impact of 6 months of treatment with the mineralocorticoid receptor blocking medication eplerenone on the heart's blood flow, using a cardiac PET stress test, and on the heart's structure and function by echocardiogram. Participants with a confirmed diagnosis of primary aldosteronism will undergo echocardiogram and cardiac PET stress test before and after 6 months of eplerenone treatment. Participants without a confirmed diagnosis of primary aldosteronism but with hypertension and a recent clinical PET test and echocardiogram will undergo testing to make the diagnosis of primary aldosteronism. Those who test positive will go on to treatment with eplerenone for 6 months, followed by a cardiac PET scan 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.

Study design

Enrollment target: 40 participants

Allocation: na

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2022-12-15

Estimated completion: 2027-02-28

Last updated: 2025-02-07

Interventions

Drug: Eplerenone

Primary outcomes

• Change in myocardial flow reserve (MFR, unitless ratio) (6 months)

Sponsor

Brigham and Women's Hospital · other

Contacts & investigators

ContactJenifer M Brown, MD · contact · jbrown35@bwh.harvard.edu · 8573071990

All locations (1)

Brigham and Women's HospitalRecruiting

Boston, Massachusetts, United States

View on ClinicalTrials.gov ↗Find similar trials