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

• Status: Not yet recruiting
• Trial end date: 2028-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Our 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. We will achieve this through a randomized, controlled, basic experimental study involving humans (BESH).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Chlorthalidone; Eplerenone

Criteria

Inclusion Criteria:

1. History of hypertension

1. Seated systolic BP < 160 mmHg and diastolic < 100 mmHg if on antihypertensives

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

2. LVH by echocardiogram

1. For men: LV mass index > 134 g/m2

2. For women: LV mass index > 110 g/m2

3. We will also allow inclusion of people with pre-diabetes and treated hypothyroidism

Exclusion Criteria:

• 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 diabetes mellitus

• Documented coronary disease (prior revascularization and/or myocardial infarction

• LV ejection fraction < 40%

• Cerebrovascular disease

• Peripheral vascular disease

• Known genetic cardiomyopathy

• Renal disease (eGFR < 60 mL/min/1.73m2)

• Hepatic disease

• Bronchospastic lung disease

• Alcohol or substance abuse

• Hormone replacement therapy

• Abnormal values for electrolytes, liver enzymes or TSH

• Hemoglobin A1c ≥ 6.5%

• Pregnancy or lactation

• All individuals <18 and >70 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.