Actively Recruiting
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
Led by Massachusetts General Hospital · Updated on 2026-04-03
204
Participants Needed
3
Research Sites
176 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
B
Brigham and Women's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Diagnosed with hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) without chronic hypertension before pregnancy
- Body mass index (BMI) of 25 kg/m2 or higher before pregnancy or in the first trimester
- Requires antihypertensive medication within one week after delivery
- Able to provide informed consent
You will not qualify if you...
- Left ventricular ejection fraction below 50% or history of heart failure
- Hypertrophic or other genetic cardiomyopathy
- High potassium levels (above 5.3 mEq/L)
- BMI of 50 kg/m2 or higher at screening
- Diabetes before pregnancy
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2
- Liver cirrhosis
- Primary aldosteronism
- Planning pregnancy within 9 months
- Active substance abuse
- Other serious medical illnesses or concerns about following the study protocol or risk of death within 9 months
- Participation in another interventional clinical trial
- Allergy or hypersensitivity to spironolactone
- Addison's disease
- Concurrent use of eplerenone or finerenone
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
Research Team
M
Michael C Honigberg, MD, MPP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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