Blood Pressure Medications for High Blood Pressure in Obesity

Overseen by Anand Vaidya, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Anand Vaidya, MD

Principal Investigator

Brigham and Women's Hospital, Harvard Medical School

Eligibility Criteria

This trial is for adults aged 18-70 with obesity (BMI ≥ 30) and at least one cardiovascular risk factor like untreated hypertension, or a BMI ≥ 25 with two such factors. Participants should not have diabetes, known heart disease history, severe kidney issues, high potassium levels, or be pregnant/breastfeeding.

Inclusion Criteria

I am between 18 and 70 years old.

My BMI is 30 or higher with at least one health issue, or it's 25 or higher with at least two.

My fasting triglycerides are over 150 mg/dL and my HDL is low.

Exclusion Criteria

I have a history of heart disease, including heart attack, failure, irregular heartbeat, or stroke.

My kidney function is reduced.

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

Treatment Details

Interventions

• Chlorthalidone with potassium chloride (Thiazide Diuretic)
• Eplerenone (Mineralocorticoid Receptor Antagonist)

Trial Overview The study tests if eplerenone can improve heart muscle blood flow and reduce scarring better than chlorthalidone plus potassium chloride in obese individuals with high aldosterone production, without considering changes in blood pressure.

Participant Groups

Group I: Eplerenone Experimental Treatment 1 Intervention

Participants will receive eplerenone, ranging from 25-100mg daily for one year.

Group II: Chlorthalidone with potassium chloride Active Control 1 Intervention

Participants will receive chlorthalidone (6.25-25mg daily for one year) along with potassium chloride (up to 20 mEq daily for one year)

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons