Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension

ConditionsHypertension Left Ventricular Hypertrophy

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorBrigham and Women's Hospital

About this trial

The investigators' goal is to show that in hypertensive men and women with left ventricular hypertrophy (LVH) treatment with a mineralocorticoid receptor (MR) antagonist, versus a thiazide-like diuretic, will improve coronary microvascular function and cardiac efficiency, which will associate with improvements in LV structure and function. The investigators will achieve this through a randomized, controlled, basic experimental study involving humans (BESH).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of hypertension

Seated systolic BP < 180 mmHg and diastolic < 110 mmHg if on antihypertensives

Seated systolic BP 141-200 mmHg and/or diastolic BP 90-114 mmHg if not on antihypertensives

LVH by echocardiogram

Disqualifiers

Use of MR antagonist (eplerenone, spironolactone, or finerenone) or amiloride (amiloride inhibits ENaC, which is a key mediator of MR's actions) within the past year

Orthostatic hypotension

Major medical illness, including uncontrolled diabetes mellitus (Hemoglobin A1c >7.5)

LV ejection fraction < 40%

Trial design

Design model

Parallel

Treatments tested in this trial

Eplerenone
Drug
After the Pre-Treatment Assessment, participants in the eplerenone arm will be given 50 mg eplerenone. At 2 weeks, eplerenone will be increased to 100 mg.
Chlorthalidone
Drug
After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.
Potassium
Drug
After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.

Treatment groups

75 Participants

are divided into 2 treatment groups

Group A: EplerenoneActive comparator 1 intervention

Group B: Chlorthalidone + potassiumActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in myocardial flow reserve

Change in myocardial flow reserve (ratio of hyperemic stress myocardial blood flow to rest myocardial blood flow)

Time frame

9 months

Secondary outcomes

Change in myocardial external efficiency

Change in myocardial external efficiency (ratio of myocardial work to oxygen consumption)

Time frame

9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

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