Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

204 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Brigham and Women's Hospital

Collaborator

University of Pittsburgh Medical Center

Collaborator