NCT07238400RecruitingPhase 2
Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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 hypertension during pregnancy and subsequently developed chronic hypertension. The main Aims are: * To test the hypothesis that, in women with prior pregnancy-induced hypertension, current chronic hypertension, and concentric LV remodeling, eplerenone improves coronary microvascular function vs. chlorthalidone. * To test the hypothesis that, in women with prior pregnancy-induced hypertension, current chronic hypertension, and concentric LV remodeling, eplerenone improves early mitral diastolic inflow velocity/annular relaxation velocity vs. chlorthalidone. Participants will: * First receive pre-treatment with Amlodipine for 12 weeks prior to beginning the study medication (participants who are already receiving amlodipine monotherapy for at least 3 months prior to randomization will proceed directly to the baseline visit). * 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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 11 Nov 2025
- Start date
- 20 Mar 2026
- Primary completion date
- 16 Mar 2029
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07238400
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 20 Mar 2026 to the primary completion date, 16 Mar 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of a mineralocorticoid receptor antagonist (MRA) or amiloride within the past 3 months or more than 30 days within the previous 12 months.
- Use of oral contraceptives, progestin depot or implant (note: progestin-containing IUD is permitted), or menopausal hormone therapy.
- 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.
Other illness
- Clinical atherosclerotic cardiovascular disease, including coronary, cerebrovascular, or peripheral artery disease.
- Diabetes mellitus.
- Any moderate or greater valvular heart disease.
- Other serious medical illnesses or concerns about protocol adherence/mortality risk within 15 months.
Lab values
- LV ejection fraction \<40% or history of clinical heart failure (reduced or preserved ejection fraction).
- 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.
- History of hypersensitivity or intolerance to calcium channel blockers, thiazides, or MRAs.
Other
- 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.
- Hypertrophic or other genetic cardiomyopathy.
- Plasma renin activity \<1 mg/mL/hour and aldosterone \>20 ng/dL (suggestive of primary aldosteronism).
- Active substance abuse.
- Participation in another interventional clinical study.
- Use of allopurinol.
- Use of lithium.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.