drugset / Trial / NCT07238400

Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

NCT07238400

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-03-20
Primary completion
2029-03-16
Completion
2029-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Chlorthalidone Other / unclassified 25 mg Oral
Comparator Eplerenone Unknown 100 mg Oral
Comparator Potassium Chloride Small molecule 20 meq Oral

Indications