Status:
COMPLETED
Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Metabolic Syndrome
Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 res...
Detailed Description
Obesity is a dominant risk factor for the development of cardiovascular disease (CVD). The public health relevance of this relationship is underscored by the fact that 40% (93 million) of adult Americ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2025
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04519164
Start Date
December 1 2020
End Date
September 17 2025
Last Update
September 22 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115