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

NCT05030545 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2021P002400
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Aldosteronism; Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in peak-stress myocardial blood flow (ml/min/g)

  6 months

• Change in Global Longitudinal Strain (%)

  6 months

• Change in LV Mass Index (g/m2 of body surface area)

  6 months

Study Arms (1)

Eplerenone Treatment

EXPERIMENTAL

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

Drug: Eplerenone

Interventions

Eplerenone 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.

Also known as: Inspra, Mineralocorticoid Receptor Antagonist

Eplerenone Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension

Interventions

Eplerenone; Mineralocorticoid Receptor Antagonists

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Diuretics, Potassium Sparing; Diuretics; Natriuretic Agents

Central Study Contacts

Jenifer M Brown, MD

CONTACT

8573071990; jbrown35@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: December 15, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)