Actively Recruiting

Phase 2
Age: 18Years - 65Years
FEMALE
NCT07238400

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Led by Massachusetts General Hospital · Updated on 2026-05-07

90

Participants Needed

2

Research Sites

158 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Brigham and Women's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to determine if the medication eplerenone yields greater improvements in coronary microvascular function than chlorthalidone in women who experienced preeclampsia during pregnancy and subsequently developed chronic hypertension. The main Aims are: * To test the hypothesis that, in women with prior preeclampsia, current chronic hypertension, and concentric LV remodeling, eplerenone improves coronary microvascular function vs. chlorthalidone. * To test the hypothesis that, in women with prior preeclampsia, current chronic hypertension, and concentric LV remodeling, eplerenone improves cardiac structure and function vs. chlorthalidone. Participants will: * First receive pre-treatment with Amlodipine for 12 weeks prior to beginning the study medication. * Start study treatment which involves daily self-administration of two oral capsules (eplerenone + potassium placebo or chlorthalidone + potassium), each taken once a day, for a total of 336 doses over 48 weeks. * Attend study visits at weeks 2, 12, 24, 36, and 48. These visits will involve collecting information, measuring blood pressure, and gathering blood and urine samples. Echocardiography (cardiac ultrasound), eye exam, and cardiac PET/CT scan will be performed during the baseline and week 48 visits.

CONDITIONS

Official Title

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with a history of preeclampsia defined by ACOG criteria in a singleton pregnancy without pre-gestational chronic hypertension
  • Current chronic hypertension (stage 1 or greater)
  • Evidence of concentric left ventricular remodeling with relative LV wall thickness greater than 0.42, with or without LV hypertrophy
  • Age 18 to 65 years at time of randomization
Not Eligible

You will not qualify if you...

  • Use of mineralocorticoid receptor antagonist or amiloride within past 3 months or more than 30 days within previous 12 months
  • Planned pregnancy, current pregnancy, or lactation
  • Systolic blood pressure greater than 150 mmHg and/or diastolic blood pressure greater than 95 mmHg while on antihypertensives, or systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg if untreated
  • Body mass index over 45 kg/m8
  • Clinical atherosclerotic cardiovascular disease including coronary, cerebrovascular, or peripheral artery disease
  • Diabetes mellitus
  • Left ventricular ejection fraction less than 40% or history of clinical heart failure
  • Hypertrophic or other genetic cardiomyopathy
  • Moderate or greater valvular heart disease
  • Estimated glomerular filtration rate less than 60 mL/min/1.73 m8
  • Urine microalbumin/creatinine ratio greater than 300 mg/g at screening
  • Abnormal electrolytes, hemoglobin, liver function tests, or TSH at screening or baseline
  • Plasma renin activity less than 1 mg/mL/hour and aldosterone greater than 20 ng/dL (suggestive of primary aldosteronism)
  • Use of oral contraceptives, progestin depot or implant (progestin-containing IUD permitted), or menopausal hormone therapy
  • History of hypersensitivity or intolerance to calcium channel blockers, thiazides, or mineralocorticoid receptor antagonists
  • Active substance abuse
  • Other serious medical illnesses or concerns about protocol adherence or mortality risk within 15 months
  • Participation in another interventional clinical study
  • Use of GLP-1 receptor agonists unless on stable dose for at least 12 months with no planned changes
  • Use of allopurinol
  • Use of lithium

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

2

Massachusetts General Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Samantha Murillo, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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