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Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

RecruitingPhase 2Ages 18 Years - anyFemaleMassachusetts General Hospital
NCT07041281 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • spironolactone 25 mg orally once daily
  • Placebo tablet to match spironolactone
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Where

3 sites
Massachusetts General Hospital
Boston, United States
Brigham and Women's Hospital
Boston, United States
University of Pittsburgh Magee-Womens Hospital
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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