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

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Eplerenone; Mineralocorticoid Receptor Antagonists; Mineralocorticoids

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.