Eplerenone versus chlorthalidone to improve heart blood vessel function after preeclampsia
Official title: Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
Run by Massachusetts General Hospital · NCT07238400 · Data updated 2026-11-12
This study will test whether eplerenone works better than chlorthalidone to improve coronary microvascular function in women who had preeclampsia and now have chronic high blood pressure and concentric left ventricular remodeling.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Status | Recruiting |
| Started | March 20, 2026 |
| Main results expected | March 16, 2029 |
| Study ends | March 30, 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07238400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18–65 who had preeclampsia in a singleton pregnancy, now have chronic hypertension and concentric LV remodeling, are not pregnant or breastfeeding, and meet the study's blood pressure and medication-use criteria.
✕Probably not a fit
Patients with diabetes, clinical atherosclerotic cardiovascular disease, reduced left ventricular ejection fraction (<40%), very high BMI (>45 kg/m²), recent mineralocorticoid antagonist use, uncontrolled hypertension above study thresholds, or who are pregnant/planning pregnancy are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized phase 2 trial enrolls women aged 18–65 with prior preeclampsia, current chronic hypertension, and evidence of concentric left ventricular remodeling. Participants receive 12 weeks of amlodipine pre-treatment and are then randomized to daily eplerenone (plus potassium placebo) or chlorthalidone (plus potassium) for the treatment period totaling 336 doses. Outcomes include changes in coronary microvascular function and cardiac structure and function measured by imaging and functional testing, with analyses to determine effects independent of blood pressure. The trial is conducted at Massachusetts General Hospital and Brigham and Women’s Hospital with NHLBI support.
Why it matters
Potential benefit: If successful, eplerenone could improve coronary microvascular function and promote healthier cardiac remodeling, lowering future cardiovascular risk for women after preeclampsia.
How similar studies have gone: Mineralocorticoid receptor antagonists have demonstrated benefits in heart failure and hypertension and preclinical data support MR involvement after preeclampsia, but randomized trials focused on coronary microvascular function after preeclampsia are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female with a history of de novo preeclampsia, gestational hypertension, or preeclampsia superimposed on chronic hypertension (defined by ACOG criteria) in a singleton pregnancy. * At least one year from last pregnancy. * 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 Criteria: * 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.
Where it's running
-
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Michael Honigberg, MD — Massachusetts General Hospital
- Study coordinator: Pearl Lee, MSc
- Email: plee23@mgh.harvard.edu
- Phone: 617-721-7783
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using low-dose aspirin after preeclampsia to improve recovery
This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.
-
IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension
This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.
-
Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF
This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.
-
Hypertension: Does Education Help Patients Manage Blood Pressure Better?
This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Long-term GW906 treatment for people with essential hypertension
This trial tests whether long-term GW906 injections are safe and effective for adults with essential hypertension who completed an earlier GW906 study.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.