Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07041281

Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Led by Massachusetts General Hospital · Updated on 2026-04-03

204

Participants Needed

3

Research Sites

176 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

B

Brigham and Women's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 years or older
  • Diagnosed with hypertensive disorders of pregnancy (gestational hypertension or preeclampsia) without chronic hypertension before pregnancy
  • Body mass index (BMI) of 25 kg/m2 or higher before pregnancy or in the first trimester
  • Requires antihypertensive medication within one week after delivery
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Left ventricular ejection fraction below 50% or history of heart failure
  • Hypertrophic or other genetic cardiomyopathy
  • High potassium levels (above 5.3 mEq/L)
  • BMI of 50 kg/m2 or higher at screening
  • Diabetes before pregnancy
  • Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2
  • Liver cirrhosis
  • Primary aldosteronism
  • Planning pregnancy within 9 months
  • Active substance abuse
  • Other serious medical illnesses or concerns about following the study protocol or risk of death within 9 months
  • Participation in another interventional clinical trial
  • Allergy or hypersensitivity to spironolactone
  • Addison's disease
  • Concurrent use of eplerenone or finerenone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

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Research Team

M

Michael C Honigberg, MD, MPP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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