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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030545
• Other study ID #: 2021P002400
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2022
• Est. completion date: February 28, 2027

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: Jenifer M Brown, MD
• Phone: 8573071990
• Email: jbrown35[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2027
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperaldosteronism
• Hypertension
• Primary Aldosteronism

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in myocardial flow reserve (MFR, unitless ratio)	The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy	6 months
Secondary	Change in peak-stress myocardial blood flow (ml/min/g)	Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment	6 months
Secondary	Change in Global Longitudinal Strain (%)	Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment	6 months
Secondary	Change in LV Mass Index (g/m2 of body surface area)	LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment	6 months