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 |
Trial Parameters
Eligibility Fast-Check
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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 f