Effects of a mineralocorticoid receptor antagonist on heart function in hypertensive patients
Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension
PHASE4 · Brigham and Women's Hospital · NCT05593055
This study is testing if a heart medication called eplerenone can improve heart function better than another medication in people with high blood pressure and thickened heart muscles.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05593055 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of a mineralocorticoid receptor (MR) antagonist, eplerenone, compared to a thiazide-like diuretic, chlorthalidone, on coronary microvascular function and cardiac efficiency in patients with hypertension and left ventricular hypertrophy (LVH). Participants will first be transitioned to enalapril and then randomized to receive either eplerenone or chlorthalidone for nine months. The study will utilize cardiac PET imaging and echocardiography to assess changes in heart function and structure, aiming to establish a correlation between treatment effects and improvements in cardiac health. The goal is to determine if MR antagonism can lead to better outcomes in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a history of hypertension and left ventricular hypertrophy as confirmed by echocardiography.
Not a fit: Patients with severe heart failure, significant comorbidities, or those currently using MR antagonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with hypertension and LVH, enhancing heart function and overall cardiovascular health.
How similar studies have performed: Previous studies have shown promising results with MR antagonists in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Gail K Adler, MD, PhD — Brigham and Women's Hospital
- Study coordinator: Gail K Adler, MD, PhD
- Email: gadler@bwh.harvard.edu
- Phone: 781-223-2686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Left Ventricular Hypertrophy