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Mineralocorticoid Receptor Antagonist

Eplerenone for High Blood Pressure

Phase 4

Recruiting

Led By Gail K Adler, MD, PhD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For men: LV mass index > 134 g/m2

For women: LV mass index > 110 g/m2

Must not have

History of secondary hypertension

Orthostatic hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will study how a mineralocorticoid receptor antagonist affects heart structure and function in people with high BP and LVH.

Who is the study for?

This trial is for men and women with high blood pressure and left ventricular hypertrophy (LVH), which means their heart's pumping chamber has thickened walls. Participants should have a history of hypertension but not severe illnesses like uncontrolled diabetes, serious heart failure, or recent major cardiovascular events. They must be between 18 to 70 years old and cannot be on certain medications like MR antagonists recently.

What is being tested?

The study tests if Eplerenone (a drug blocking certain hormone receptors) is better than Chlorthalidone (a diuretic) at improving heart vessel function and efficiency in people with LVH due to high blood pressure. It's a randomized controlled trial where participants are assigned by chance to one of the treatments.

What are the potential side effects?

Possible side effects include changes in potassium levels that can affect the heart rhythm, kidney function issues, dehydration from increased urination with Chlorthalidone, and potential hormonal imbalances with Eplerenone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's muscle mass is above the normal range.

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My heart's left ventricle mass index is over 110 g/m2.

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My blood pressure is below 180/110 mmHg while on medication.

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My blood pressure is high but I'm not on blood pressure medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had high blood pressure caused by another condition.

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I experience significant drops in blood pressure when standing up.

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I have not had a heart attack, stroke, or major heart procedure in the last 6 months.

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I have a liver condition.

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I have severe heart failure or unstable chest pain.

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My diabetes is under control (HbA1c ≤ 7.5).

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I have a genetic heart muscle disorder.

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My kidney function is normal, with creatinine levels below 1.5 mg/dL for men and 1.3 mg/dL for women.

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I am on hormone replacement therapy.

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I am between 18 and 70 years old.

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I have a lung condition that causes my airways to narrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in myocardial flow reserve

Secondary study objectives

Change in myocardial external efficiency

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Group I: EplerenoneActive Control1 Intervention

Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 50 mg eplerenone . At 2 weeks, eplerenone will be increased to 100 mg. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of \<135/85 mmHg.

Group II: Chlorthalidone + potassiumActive Control2 Interventions

Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of \<135/85 mmHg.

0 / 15Eligibility criteria met