Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia

Conditions

• Hypertension

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Eplerenone 100 mg daily — DRUG
  Participants with a history of preeclampsia and current chronic hypertension will receive 100mg capsules of eplerenone to self-administer daily over the 48-week duration of the study treatment.
• Chlorthalidone 25 mg daily — DRUG
  Participants with a history of preeclampsia with current chronic hypertension will receive 25mg capsules of chlorthalidone to self-administer daily over the 48-week duration of the study treatment.
• Potassium Placebo — DRUG
  Participants taking eplerenone will also take a potassium placebo to self-administer daily over the 48-week duration of the study treatment.
• Potassium Chloride — DRUG
  Participants taking chlorthalidone will also take 20 mEq of potassium to self-administer daily over the 48-week duration of the study treatment.

Study Details

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.

Key Dates

Start date

Mar 20, 2026

Status verified

May 2026

Primary completion

Mar 16, 2029

Completion

Mar 30, 2029

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change in Myocardial Flow Reserve (MFR) [ Time Frame: Prior to randomization and after 48 weeks of randomized study treatment. ]

Central Contacts

• Samantha Murillo, MSc
  860-336-6097
  [email protected]

Locations (2)

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