Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05593055

Conditions

Hypertension

Left Ventricular Hypertrophy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Eplerenone

Chlorthalidone

Potassium

Study Details

Brief summary:

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).

Conditions

Hypertension

Left Ventricular Hypertrophy

Study ID

NCT05593055

Start date

Aug 25, 2023

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Eplerenone

Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 50 mg eplerenone . At 2 weeks, eplerenone will be increased to 100 mg. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of <135/85 mmHg.

active comparator: Chlorthalidone + potassium

Participants be placed on enalapril 10 mg and weaned off their other anti-hypertensives prior to the Pre-Treatment Assessment. Amlodipine (5 to 10 mg) will be added if needed to control blood pressure. After the Pre-Treatment Assessment, participants randomized to this arm will receive 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium. Amlodipine (5 to 10 mg) will be added at 6 weeks or later if needed to achieve the BP target of <135/85 mmHg.

Interventions

Eplerenone

After the Pre-Treatment Assessment, participants in the eplerenone arm will be given 50 mg eplerenone. At 2 weeks, eplerenone will be increased to 100 mg.

Chlorthalidone

After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.

Potassium

After the Pre-Treatment Assessment, participants in the chlorthalidone arm will be given 12.5 mg chlorthalidone + 10 mEq potassium. At 2 weeks, chlorthalidone will be increased to 25 mg + 20 mEq potassium.

Primary outcome measure

  • Change in myocardial flow reserve [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Gail K Adler, MD, PhD

781-223-2686gadler@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Gail K Adler, MD, PhD

617-732-6660gadler@partners.org

Principal Investigator:

Gail K Adler, MD, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Apr 6, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-04-06.