Pilot Study of Eplerenone for Heart Health in Primary Aldosteronism

This study is exploring how the medication eplerenone might improve heart health in people with primary aldosteronism (a condition where your body makes too much of the hormone aldosterone, leading to high blood pressure). Researchers want to see if 6 months of treatment with eplerenone can improve blood flow in your heart. You may be able to join if you are an adult between 18 and 85 years old, have high blood pressure, and have a confirmed diagnosis of primary aldosteronism. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an interventional pilot study with no specified phase, planning to enroll 40 participants. It evaluates the effect of eplerenone treatment.
What's involved
You would receive eplerenone daily for 6 months. Before and after this treatment, you would have heart imaging tests, including a PET scan and an echocardiogram.
Compensation
Not stated in the trial record.
Follow-up
Your heart's blood flow will be measured at 6 months, which is the end of the treatment period.

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NCT05030545

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

Recruiting
PHASE4Ages 18–85InterventionalTreatment
Brigham and Women's Hospital
~40 participants
Updated 2025-02-07 on ClinicalTrials.gov
What's tested:Eplerenone

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in myocardial flow reserve (MFR, unitless ratio)
Measured over 6 months
Primary Aldosteronism
Hypertension
1 sites across 1 states
Massachusetts1

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Eligibility criteria

Inclusion

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
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

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

    The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy