NCT07041281RecruitingPhase 2
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- 16 Oct 2025
- Primary completion date
- 2 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- High blood pressure
- NCT number
- NCT07041281
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 204
- From 16 Oct 2025 to the primary completion date, 2 Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of eplerenone or finerenone
Other illness
- Pre-pregnancy diabetes
- Other serious medical illnesses or concerns about protocol adherence/ mortality within 9 months
- Hypersensitivity to spironolactone
- Addison's disease
Lab values
- LV ejection fraction \<50% or history of clinical heart failure with reduced or preserved ejection fraction
- Hyperkalemia: potassium \>5.3 mEq/L
- Estimated glomerular filtration rate (eGFR) \<60mL/min/1.73 m2
Other
- Hypertrophic or other genetic cardiomyopathy
- BMI at screening ≥50 kg/m2
- Cirrhosis
- Primary aldosteronism
- Intention to become pregnant within 9 months
- Active substance abuse
- Participation in another interventional clinical study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Pittsburgh Magee-Womens Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.