NCT07041281 Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories
| NCT ID | NCT07041281 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2027-12-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 204 participants in total. It began in 2025-10-16 with a primary completion date of 2027-12-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07041281 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07041281 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07041281 currently recruiting?
Yes, NCT07041281 is actively recruiting participants. Contact the research team at mhonigberg@mgh.harvard.edu for enrollment information.
Where is the NCT07041281 trial being conducted?
This trial is being conducted at Boston, United States, Boston, United States, Pittsburgh, United States.
Who is sponsoring the NCT07041281 clinical trial?
NCT07041281 is sponsored by Massachusetts General Hospital. The trial plans to enroll 204 participants.