Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called spironolactone can help women who had high blood pressure during pregnancy, such as preeclampsia or gestational hypertension. These conditions can increase the risk of ongoing heart problems after pregnancy, especially in women who were overweight before getting pregnant. The study will test if taking spironolactone for three months after giving birth can improve blood pressure and heart health by nine months postpartum.

Women who might be eligible for this study are those aged 18 or older who had high blood pressure starting during pregnancy (but not before), had a body mass index (BMI) of 25 or higher before or early in pregnancy, and needed blood pressure medicine when leaving the hospital after delivery. Participants will be closely monitored and will need to be able to give informed consent. Some health conditions like serious heart problems, very high potassium levels, diabetes before pregnancy, or plans to become pregnant again soon would exclude someone from joining. If you join, you can expect to take the study medicine for a few months after delivery and have follow-up visits to check your blood pressure and heart function. This study is not yet recruiting participants.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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 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 (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