Spironolactone to improve blood pressure after pregnancy-related hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled Phase 2 trial giving spironolactone 25 mg once daily or matching placebo for three months beginning in the early postpartum period to women with gestational hypertension or preeclampsia and pre-pregnancy overweight/obesity. Participants must have required antihypertensive medication within one week of delivery and have no pre-pregnancy chronic hypertension. The study measures blood pressure and cardiac structure/function out to nine months postpartum to detect durable effects on blood pressure trajectories and cardiac remodeling. Safety monitoring includes checks of potassium and kidney function and exclusion criteria to reduce risk from mineralocorticoid receptor blockade.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• University of Pittsburgh Magee-Womens Hospital
  Pittsburgh, Pennsylvania, United States Not yet recruiting

Study contacts

• Study coordinator: Michael C Honigberg, MD, MPP
• Email: mhonigberg@mgh.harvard.edu
• Phone: 617-726-1843

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.