Recruiting
Phase 2

Mineralocorticoid Receptor Blockade

Sponsor:

Massachusetts General Hospital

Code:

NCT07041281

Conditions

Preeclampsia

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

spironolactone 25 mg orally once daily

Placebo tablet to match spironolactone

Study Details

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.

Conditions

Preeclampsia

Gestational Hypertension

Study ID

NCT07041281

Start date

Oct 16, 2025

Status verified date

Apr, 2026

Completion date

Mar 2, 2029

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

spironolactone 25 mg orally once daily

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

Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules 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 and Locations

Central contacts

Michael C Honigberg, MD, MPP

617-726-1843mhonigberg@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Victoria R Viscosi, MS

617-724-2996vviscosi@mgh.harvard.edu

Principal Investigator:

Michael C Honigberg, MD, MPP

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Maria A. Pabon, MD

857-407-4561mpabonporras@bwh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Apr 3, 2026

Last verified

Apr, 2026

Keywords

  • preeclampsia
  • gestational hypertension
  • spironolactone
  • blood pressure
  • hypertension
  • pregnancy
  • echocardiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-04-03.