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Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to determine if the medication eplerenone yields greater improvements in coronary microvascular function than chlorthalidone in women who experienced preeclampsia during pregnancy and subsequently developed chronic hypertension. The main Aims are: * To test the hypothesis that, in women with prior preeclampsia, current chronic hypertension, and concentric LV remodeling, eplerenone improves coronary microvascular function vs. chlorthalidone. * To test the hypothesis that, in women with prior preeclampsia, current chronic hypertension, and concentric LV remodeling, eplerenone improves cardiac structure and function vs. chlorthalidone. Participants will: * First receive pre-treatment with Amlodipine for 12 weeks prior to beginning the study medication. * Start study treatment which involves daily self-administration of two oral capsules (eplerenone + potassium placebo or chlorthalidone + potassium), each taken once a day, for a total of 336 doses over 48 weeks. * Attend study visits at weeks 2, 12, 24, 36, and 48. These visits will involve collecting information, measuring blood pressure, and gathering blood and urine samples. Echocardiography (cardiac ultrasound), eye exam, and cardiac PET/CT scan will be performed during the baseline and week 48 visits.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Female with a history of preeclampsia (defined by ACOG criteria) in a singleton pregnancy without pre-gestational chronic hypertension.

• Current chronic hypertension (stage 1 or greater).

• Evidence of concentric left ventricular (LV) remodeling, defined as relative LV wall thickness \>0.42, with or without LV hypertrophy.

• Age 18-55 years at time of randomization.

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Samantha Murillo, MSc
smurillo2@mgh.harvard.edu
860-336-6097
Time Frame
Start Date: 2026-03-20
Estimated Completion Date: 2029-03-30
Participants
Target number of participants: 90
Treatments
Active_comparator: Eplerenone
Participants will receive eplerenone 100 mg daily plus potassium placebo for 48 weeks
Active_comparator: Chlorthalidone
Participants will receive chlorthalidone 25 mg plus potassium 20 mEq daily for 48 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov