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

Preeclampsia Gestational Hypertension

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

Inclusion Criteria5

Females aged ≥18 years
Antepartum-onset 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 on postpartum discharge
Ability to provide informed consent

Exclusion Criteria15

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 (to ensure accurate BP measurement and adequate echocardiographic images for analysis)
Pre-pregnancy diabetes
Estimated glomerular filtration rate (eGFR) \<60mL/min/1.73 m2
Cirrhosis
Primary aldosteronism
Intention to become pregnant within 9 months
Active substance abuse
Other serious medical illnesses or concerns about protocol adherence/ mortality within 9 months
Participation in another interventional clinical study
Hypersensitivity to spironolactone
Addison's disease
Concomitant use of eplerenone or finerenone

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.