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

Recruiting now · Phase 4

Conditions studied: Hypertension, Left Ventricular Hypertrophy

In brief

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).

Key facts

Study ID

NCT05593055

Run by

Brigham and Women's Hospital

People needed

75

Starts

2023-08-25

Expected to finish

2027-12-31

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• For men: interventricular septum thickness ≥ 12mm
• For women: interventricular septum thickness ≥ 11mm
• We will also allow inclusion of people with treated hypothyroidism, pre-diabetes and diabetes controlled by diet, exercise, and/or metformin.

You may not qualify if…

• 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%
• New York Heart Association class III to IV congestive heart failure or unstable angina
• A history in the prior 6 months of Q-wave myocardial infarction, stroke, transient ischemic attack, percutaneous transluminal coronary angioplasty, or coronary artery bypass graft
• History of secondary hypertension
• Known genetic cardiomyopathy
• Renal disease (seum creatinine >1.5 mg/dL for men and >1.3 mg/dL for women)
• Hepatic disease
• Bronchospastic lung disease
• Alcohol or substance abuse
• Hormone replacement therapy
• Abnormal values for electrolytes, liver enzymes or TSH
• Pregnancy or lactation
• All individuals <18 and >75 years will be excluded due to safety concerns of administering an angiotensin-II infusion in these patient groups.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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