RecruitingPhase 2NCT07041281

Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories


Sponsor

Massachusetts General Hospital

Enrollment

204 participants

Start Date

Oct 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The hypertensive disorders of pregnancy (preeclampsia and gestational hypertension) are associated with increased long-term maternal risk of developing cardiovascular disease. Recent evidence suggests that activation of the mineralocorticoid receptor promotes ongoing susceptibility to hypertension in women following hypertensive disorders of pregnancy. In addition, women with overweight/obesity are at increased risk for progression to chronic hypertension after experiencing hypertensive disorders of pregnancy. Among women with hypertensive disorders of pregnancy and pre-pregnancy overweight/obesity, the investigators will conduct a randomized trial to test the effect of pharmacologically blocking the mineralocorticoid receptor for three months after delivery on blood pressure and cardiac remodeling at nine months postpartum.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether spironolactone — a blood pressure medication — can help women return to normal blood pressure more quickly after developing high blood pressure during pregnancy (a condition called hypertensive disorder of pregnancy, or HDP). High blood pressure during pregnancy can persist after giving birth, and this study wants to see if spironolactone speeds up recovery. **You may be eligible if...** - You are 18 or older - You developed high blood pressure or preeclampsia during your pregnancy (not from a pre-existing condition) - Your BMI was 25 or higher before pregnancy or in your first trimester - You were still on blood pressure medication when you left the hospital after giving birth **You may NOT be eligible if...** - Your heart's pumping function is reduced, or you have a history of heart failure - You have a genetic heart condition (such as hypertrophic cardiomyopathy) - You have significantly reduced kidney function - Your potassium levels are already high - You are currently breastfeeding (if the medication is not safe for breastfeeding) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGspironolactone 25 mg orally once daily

Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment.

DRUGPlacebo tablet to match spironolactone

Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.


Locations(3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

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NCT07041281


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