Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Pennsylvania
University of Pittsburgh Magee-Womens Hospital
NOT_YET_RECRUITING
Pittsburgh
Contact Information
Primary
Michael C Honigberg, MD, MPP
mhonigberg@mgh.harvard.edu
617-726-1843
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2029-03-02
Participants
Target number of participants: 204
Treatments
Placebo_comparator: Placebo: Control
Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.
Experimental: Treatment: Spironolactone
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.
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital, University of Pittsburgh Medical Center
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov