RightFit
RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 9 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be transitioned to enalapril, ACEi, with washout of all other anti-hypertensives and then randomized to add-on treatment for 9 months with eplerenone (MR antagonist) or chlorthalidone (thiazide-like diuretic) + potassium."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 ≥ 12mm 2. For women: interventricular septum thickness ≥ 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.

Study sites (1)

MA