RightFit
RecruitingPhase 2

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 48 visits
  • Procedures mentioned: Urine samples, CT scans, Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The investigators will measure coronary microvascular function (myocardial flow reserve, i.e., hyperemic stress/rest myocardial blood flow) quantified by cardiac positron emission tomography (PET/CT) and cardiac structure and function by cardiac ultrasound at baseline and 48 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares eplerenone with chlorthalidone to see which better improves blood flow in the heart’s small vessels and the heart’s shape and function. It is for women who had preeclampsia, a high blood pressure condition during pregnancy, and now have long-term high blood pressure and thickened heart walls.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a woman age 18–65.
  • You had preeclampsia during a pregnancy with one baby, with no long-term high blood pressure before that pregnancy.
  • You now have long-term high blood pressure, stage 1 or higher.
  • The walls of your heart’s main pumping chamber are thick compared with its size, with a wall thickness ratio above 0.42.

Who can't join

  • You are pregnant, plan to become pregnant, or are breastfeeding.
  • Your blood pressure is above 150/95 while taking blood pressure medicine, or above 160/100 without it. Either number above the limit counts. Your body mass index (BMI), a measure based on height and weight, is above 45.
  • You have diabetes, disease from clogged arteries, past heart failure, or a heart pumping level below 40%. Certain inherited heart muscle diseases or moderate or worse heart valve disease also rule you out.
  • Kidney tests show a filtering rate below 60 or a urine protein-to-creatinine ratio above 300. Certain abnormal blood, liver, thyroid, or hormone test results also rule you out.
  • You used an MRA medicine or amiloride in the past 3 months, or for more than 30 days in the past year. You take allopurinol, lithium, birth control pills, a progestin shot or implant, or menopause hormones. A progestin IUD is allowed.
  • You cannot tolerate calcium channel blockers, thiazides, or MRAs, which are types of blood pressure medicines.
  • You have active substance abuse, another serious illness, or concerns about following study steps or surviving the next 15 months. You are in another study that tests a treatment.
  • You use a GLP-1 medicine but have not stayed on the same medicine, form, and steady dose for at least 12 months. Breaks of up to 4 weeks are allowed if you restart the same medicine and dose. You cannot plan to change or stop it at enrollment, or start one after treatment assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 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.

Study sites (2)

MA