Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
NCT07041281 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2026-04-03
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.
Conditions
- Preeclampsia
- Gestational Hypertension
Interventions
- DRUG
-
spironolactone 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.
- DRUG
-
Placebo 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.
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER -
University of Pittsburgh Medical Center
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-16
- Primary Completion
- 2027-12-02
- Completion
- 2029-03-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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