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

Phase 4

Recruiting

• Conditions: Primary Aldosteronism; Hypertension
• Interventions: Drug: Eplerenone

• Registration Number: NCT05030545
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-09-01
• Study Start: 2022-12-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-10-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eplerenone Treatment	Eplerenone	Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change in LV Mass Index (g/m2 of body surface area)	6 months	LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment
Change in peak-stress myocardial blood flow (ml/min/g)	6 months	Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment
Change in Global Longitudinal Strain (%)	6 months	Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States