Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension
Recruiting · NCT05593055 · Interventional (participants receive a specific treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
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 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
1 location listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States