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

NCT ID: NCT05030545

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2027-02-28

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.

Conditions

Primary Aldosteronism; Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eplerenone Treatment

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

Group Type: EXPERIMENTAL

Eplerenone

Intervention Type: 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.

Interventions

Eplerenone

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.

Intervention Type: DRUG

Other Intervention Names

Inspra; Mineralocorticoid Receptor Antagonist

Eligibility Criteria

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

• 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 A: Planned adrenalectomy in the subsequent 6 months

Cohort B: Subclinical & Undiagnosed PA

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jenifer M. Brown, M.D.

Instructor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jenifer M Brown, MD

Role: CONTACT

jbrown35@bwh.harvard.edu

8573071990

Facility Contacts

Eva Abel

Role: primary

617-525-3803

Other Identifiers

2021P002400

Identifier Type: -

Identifier Source: org_study_id