Spironolactone to improve blood pressure after pregnancy-related hypertension
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
This trial will try taking spironolactone for three months after delivery to see if it lowers blood pressure and prevents heart changes in women who had preeclampsia or gestational hypertension and were overweight before pregnancy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT07041281 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled Phase 2 trial giving spironolactone 25 mg once daily or matching placebo for three months beginning in the early postpartum period to women with gestational hypertension or preeclampsia and pre-pregnancy overweight/obesity. Participants must have required antihypertensive medication within one week of delivery and have no pre-pregnancy chronic hypertension. The study measures blood pressure and cardiac structure/function out to nine months postpartum to detect durable effects on blood pressure trajectories and cardiac remodeling. Safety monitoring includes checks of potassium and kidney function and exclusion criteria to reduce risk from mineralocorticoid receptor blockade.
Who should consider this trial
Good fit: Women aged 18 or older who had gestational hypertension or preeclampsia, were overweight or obese before pregnancy (BMI ≥25 kg/m2), required antihypertensive medication within one week of delivery, and can provide informed consent are the ideal candidates.
Not a fit: Women with reduced left ventricular ejection fraction, significant kidney dysfunction or hyperkalemia, pre-pregnancy diabetes, BMI ≥50 kg/m2, known spironolactone hypersensitivity, or those planning pregnancy within 9 months are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, a short course of spironolactone after delivery could lower postpartum blood pressure and reduce the chance of developing chronic hypertension and adverse cardiac remodeling in these women.
How similar studies have performed: Preclinical data and the POP-HT trial support the importance of early postpartum blood pressure control and a role for mineralocorticoid receptor pathways, but randomized trials of postpartum spironolactone for this purpose are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- University of Pittsburgh Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Michael C Honigberg, MD, MPP
- Email: mhonigberg@mgh.harvard.edu
- Phone: 617-726-1843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.