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

Mass General Brigham

Status and phase

Enrolling

Phase 4

Conditions

Hypertension

Primary Aldosteronism

Treatments

Drug: Eplerenone

Study type

Interventional

Funder types

Other

Identifiers

NCT05030545

2021P002400

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.