Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity

• Status: Recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether the mineralocorticoid receptor antagonist eplerenone, when compared to chlorthalidone plus potassium chloride, can improve cardiac MRI-derived myocardial perfusion reserve and fibrosis, independent of blood pressure, and proportionately to the severity of autonomous aldosterone production.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Chlorthalidone; Eplerenone

Criteria

Inclusion Criteria:

1. BMI ≥ 30 with at least one of the following, or BMI ≥ 25 with at least two of the following:

1. Untreated Hypertension: Stage I (BP 120-139/80-89 mmHg) or stage II (BP 140-159/90-99 mmHg).

2. Treated Hypertension: On one anti-hypertensive medication with BP<140/90 mmHg and willing to undergo a 2-week washout of the medication before initiating eplerenone or chlorthalidone + KCl

3. Dysglycemia: Impaired fasting plasma glucose (100-125 mg/dL) or glycated A1c 5.7-6.4%

4. Dyslipidemia: Fasting triglyceride level > 150 mg/dL and HDL< 40 mg/dL in men or <50 mg/dL in women.

2. Age between 18 and 70 years old

Exclusion Criteria:

• Estimated glomerular filtration rate < 60 mL/min/1.73m2)

• Serum potassium > 5.2 mEq/L

• Known diagnosis or treatment for type 1 or type 2 diabetes

• Known history of CVD (myocardial infarction, heart failure, atrial fibrillation, or stroke)

• EKG with ischemic ST-segment or T-wave changes or Q waves in more than one territorial lead or a left bundle branch block

• Pregnancy (verified with a pregnancy test) or breast-feeding