Clinical trial for Hypertension
Official title Cardiac Effects of Mineralocorticoid Receptor Antagonism After Hypertensive Disorders of Pregnancy
ClinicalTrials.gov ID: NCT07238400
What this study is testing
What is Eplerenone 100 mg daily?
An investigational oral medication being studied for its potential to improve coronary microvascular function in women with a history of preeclampsia and chronic hypertension. It is designed to block mineralocorticoid receptors, which may influence blood pressure and heart function.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares two blood‑pressure medicines to see if eplerenone better improves small‑vessel heart function and heart structure in women who had preeclampsia and now have chronic high blood pressure.
- Who it's for
- Women who had preeclampsia during pregnancy, now have chronic hypertension, and show thickening of the heart’s left ventricle.
- What's involved
- Participants take a daily pill (either eplerenone with a potassium placebo or chlorthalidone with potassium) for 48 weeks, attend visits every 12 weeks, and have blood pressure checks, blood and urine tests, an eye exam, and heart imaging at the start and end.
- Time commitment
- The study lasts 48 weeks, with visits at weeks 2, 12, 24, 36, and 48, plus baseline and final imaging tests.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 48 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Female with a history of de novo preeclampsia, gestational hypertension, or preeclampsia superimposed on chronic hypertension (defined by ACOG...
- 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.
You likely can't join if
- 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...
- BMI \>45 kg/m².
- Clinical atherosclerotic cardiovascular disease, including coronary, cerebrovascular, or peripheral artery disease.
- Diabetes mellitus.
See the full eligibility 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.
- 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 \ 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 treatment 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.
- Use of allopurinol.
- Use of lithium.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 48 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.