Recruiting

Aldosterone with Medication

Sponsor:

Brigham and Women's Hospital

Code:

NCT05030545

Conditions

Primary Aldosteronism

Hypertension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Eplerenone

Study Details

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

Study ID

NCT05030545

Start date

Dec 15, 2022

Status verified date

Feb, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eplerenone Treatment

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

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.

Primary outcome measure

  • Change in myocardial flow reserve (MFR, unitless ratio) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jenifer M Brown, MD

8573071990jbrown35@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Eva Abel

617-525-3803

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 7, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-02-07.