๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. History of hypertension
1. Seated systolic BP \< 180 mmHg and diastolic \< 110 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: interventricular septum thickness โฅ 12mm
2. For women: interventricular septum thickness โฅ 11mm
3. 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.
๐
What it tests
- Eplerenone
- Chlorthalidone
- Potassium
Brigham and Women's Hospital
Boston, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.