CompletedPhase 4

Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity

United States79 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. BMI ≥ 30 with at least one of the following, or BMI ≥ 25 with at least two of the following:
✓. Untreated Hypertension: Stage I (BP 120-139/80-89 mmHg) or stage II (BP 140-159/90-99 mmHg).
✓. 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
✓. Dysglycemia: Impaired fasting plasma glucose (100-125 mg/dL) or glycated A1c 5.7-6.4%
✓. Dyslipidemia: Fasting triglyceride level \> 150 mg/dL and HDL\< 40 mg/dL in men or \<50 mg/dL in women.
✓. Age between 18 and 70 years old

What they're measuring

Change in stress myocardial perfusion reserve on cardiac MRI

Timeframe: one year

Trial details

NCT IDNCT04519164

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-17

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