Eplerenone vs. Chlorthalidone for Heart Health After Preeclampsia

This study is looking at how two medications, eplerenone (100 mg daily) and chlorthalidone (25 mg daily), affect the heart in women who had preeclampsia (a serious blood pressure condition during pregnancy) and now have ongoing high blood pressure. The goal is to see if eplerenone improves the small blood vessels in the heart more than chlorthalidone. You might be able to join if you are a woman between 18 and 65, had preeclampsia in a single pregnancy, currently have high blood pressure, and show signs of changes in your heart's structure. The main way they will measure success is by looking at changes in your Myocardial Flow Reserve (MFR), which shows how well blood flows through your heart. The study is currently unclear about its status, but plans to enroll 90 participants.

Study design
This is an interventional study comparing two different medications. It plans to enroll 90 women.
What's involved
Participants will take either eplerenone or chlorthalidone daily for 48 weeks, along with a potassium supplement or placebo. Before starting the study medication, you will take Amlodipine for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Myocardial Flow Reserve, will be measured after 48 weeks of study treatment.

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NCT07238400

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Recruiting
PHASE2Ages 18–65InterventionalTreatment
Massachusetts General Hospital
~90 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Eplerenone 100 mg dailyChlorthalidone 25 mg dailyPotassium PlaceboPotassium Chloride

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Myocardial Flow Reserve (MFR)
Measured over Prior to randomization and after 48 weeks of randomized study treatment.
Hypertension
2 sites across 1 states
Massachusetts2
  • Michael Honigberg, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Eligibility criteria

Inclusion

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 (LV) remodeling, defined as relative LV wall thickness \>0.42, with or without LV hypertrophy.
Age 18-65 years at time of randomization.

Exclusion

Use of a mineralocorticoid receptor antagonist (MRA) or amiloride within the past 3 months or more than 30 days within the previous 12 months.
Planned pregnancy, current pregnancy, or lactation.
Systolic BP \>150 mmHg and/or diastolic BP \>95 mmHg while on antihypertensives, or systolic BP \>160 mmHg and/or diastolic BP \>100 mmHg if untreated.
BMI \>45 kg/m².
Clinical atherosclerotic cardiovascular disease, including coronary, cerebrovascular, or peripheral artery disease.
Diabetes mellitus.
LV ejection fraction \<40% or history of clinical heart failure (reduced or preserved ejection fraction).
Hypertrophic or other genetic cardiomyopathy.
Any moderate or greater valvular heart disease.
eGFR \<60 mL/min/1.73 m².
Urine microalbumin/creatinine ratio \>300 mg/g at screening.
Abnormal electrolytes, hemoglobin, liver function tests, or TSH at screening or baseline.
Plasma renin activity \<1 mg/mL/hour and aldosterone \>20 ng/dL (suggestive of primary aldosteronism).
Use of oral contraceptives, progestin depot or implant (note: progestin-containing IUD is permitted), or menopausal hormone therapy.
History of hypersensitivity or intolerance to calcium channel blockers, thiazides, or MRAs.
Active substance abuse.
Other serious medical illnesses or concerns about protocol adherence/mortality risk within 15 months.
Participation in another interventional clinical study.
Participants using GLP-1 receptor agonists (GLP-1RA) are eligible only if they have received continuous treatment with the same GLP-1RA agent at an unchanged maintenance dose for ≥12 months prior to enrollment. Dose changes, agent switches, or formulation changes within the 12 months preceding enrollment are not permitted. Temporary interruptions of ≤4 consecutive weeks (e.g., due to supply issues or procedural holds) are allowed, provided the same agent and dose are resumed. At the time of enrollment, there must be no planned or anticipated GLP-1RA dose escalation, dose reduction, or discontinuation. Initiation of GLP-1RA therapy after randomization is not permitted. Dose changes during follow-up are discouraged unless clinically required.
Use of allopurinol.
Use of lithium.
  • Change in Myocardial Flow Reserve (MFR)Prior to randomization and after 48 weeks of randomized study treatment.

    Subjects will undergo 13N cardiac PET imaging at baseline and after 48 weeks of randomized study treatment. Myocardial blood flow (MBF) will be determined during the stress and rest conditions. Myocardial flow reserve will be calculated as stress MBF divided by rest MBF.