Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
Massachusetts General Hospital
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.
Description
The hypertensive disorders of pregnancy (HDP, e.g., gestational hypertension and preeclampsia) are a leading cause of maternal and infant morbidity and mortality and are associated with increased long-term risk of maternal atherosclerotic cardiovascular disease (CVD) and heart failure. The American College of Cardiology and American Heart Association now recognize the HDP as a sex-specific CVD risk factor to guide prescription of preventive statin therapy. Beyond this focused recommendation, however, targeted strategies for CVD risk reduction in women with HDP are not yet established. Maternal…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Females aged ≥18 years * HDP (gestational hypertension or preeclampsia) without pre-pregnancy chronic hypertension * BMI ≥25 kg/m2 prior to pregnancy or in the first trimester * Requirement for antihypertensive medication within one week of delivery * Ability to provide informed consent Exclusion Criteria: * LV ejection fraction \<50% or history of clinical heart failure with reduced or preserved ejection fraction * Hypertrophic or other genetic cardiomyopathy * Hyperkalemia: potassium \>5.3 mEq/L * BMI at screening ≥50 kg/m2 * Pre-pregnancy diabetes * Estimated glomer…
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 HospitalBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts
- University of Pittsburgh Magee-Womens HospitalPittsburgh, Pennsylvania