Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07041281
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Gestational Hypertension
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • spironolactone 25 mg orally once daily — DRUG
    Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment.
  • Placebo tablet to match spironolactone — DRUG
    Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.

Study Details

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.

Key Dates

Start date
Oct 16, 2025
Status verified
Apr 2026
Primary completion
Dec 2, 2027
Completion
Mar 2, 2029

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo: Control
    Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.
  • Experimental: Treatment: Spironolactone
    Participants with hypertensive disorders of pregnancy will receive 25mg capsules of spironolactone to self-administer daily over the 12-week duration of the study treatment.

Primary Outcome Measure

Mean 24-hour ambulatory diastolic blood pressure [ Time Frame: 36 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Maria A. Pabon, MD
[email protected]
857-407-4561
Massachusetts General HospitalBostonMassachusetts02114
Victoria R Viscosi, MS
[email protected]
617-724-2996
Michael C Honigberg, MD, MPP (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Magee-Womens HospitalPittsburghPennsylvania15213
Malamo E Countouris, MD, MS
[email protected]
412-569-4229

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By research site
Brigham and Women's Hospital· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Pittsburgh Magee-Womens Hospital· Pittsburgh, PA

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