Effects of a mineralocorticoid receptor antagonist on heart function in hypertensive patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.