Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories

NCT07041281 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2025P00119525SFRNPCKMS1463898STUDY25060149
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mean 24-hour ambulatory diastolic blood pressure

  24-hour BP monitoring will be performed as part of end-of-study assessments using a validated ambulatory BP monitor.

  36 weeks

Secondary Outcomes (31)

• Left ventricular relative wall thickness (main echocardiographic outcome)

  Baseline and 36 weeks

• Mean 24-hour ambulatory systolic blood pressure

  36 weeks

• Mean diurnal ambulatory systolic blood pressure

  36 weeks

• Mean diurnal ambulatory diastolic blood pressure

  36 weeks

• Mean nocturnal ambulatory systolic blood pressure

  36 weeks

Study Arms (2)

Placebo: Control

PLACEBO COMPARATOR

Participants with Hypertensive disorders of pregnancy will receive placebo equivalent capsules to self-administer daily over the 12-week duration of the study treatment.

Drug: Placebo tablet to match spironolactone

Treatment: Spironolactone

EXPERIMENTAL

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.

Drug: spironolactone 25 mg orally once daily

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.

Treatment: Spironolactone

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.

Placebo: Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged ≥18 years
• Antepartum-onset 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 on postpartum discharge
• Ability to provide informed consent

You may not qualify if:

• 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 (to ensure accurate BP measurement and adequate echocardiographic images for analysis)
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator
• University of Pittsburgh Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Pittsburgh Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Michael C Honigberg, MD, MPP

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized, double-blind, placebo-controlled trial of low-dose spironolactone versus placebo in women with pre-pregnancy overweight/obesity who develop de novo hypertensive disorders of pregnancy

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): March 2, 2029
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)