Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia (REPAIR)

Medical College of Wisconsin

Status: Enrolling

Conditions: Hypertension, Pregnancy-Induced

Treatments: Drug: Nifedipine ER

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06220721

PRO00049909

1R01HD112930-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

Full description

The REPAIR trial is a multicenter randomized controlled trial of 618 postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The intervention group will receive intensive blood pressure (BP) control with nifedipine extended-release initiation when BP is ≥ 140/90 mmHg. The active control group will receive usual care with nifedipine ER initiation when BP is ≥ 150/100. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. Specifically, cardiac function and structure will be assessed with transthoracic echocardiogram, endothelial dysfunction with brachial artery flow-mediated dilation, and arterial stiffness with carotid-femoral pulse wave velocity. The primary outcome is the incident diagnosis of stage I hypertension at one year postpartum.

Enrollment: 618 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension or preeclampsia, according to ACOG guidelines
• Postpartum day 0-4
• Able to communicate in English or in Spanish
• Has an established OBGYN at an MCW or NU health system practice that has access to Epic electronic medical records.

Exclusion criteria

• Pre-gestational hypertension
• Type 1 or type 2 diabetes mellitus
• Admitted to intensive care unit at the time of screening
• Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization
• Getting discharged on the day of screening
• Known allergy or contraindication to nifedipine ER
• Inability or unwillingness to provide informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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618 participants in 2 patient groups

REPAIR ARM

Experimental group

Description:

Intensive postpartum blood pressure control with nifedipine ER initiation at systolic blood pressure (SBP) ≥140 mmHg or diastolic blood pressure (DBP) ≥90 mmHg and maintaining blood pressure \<140/90 mmHg during the first 6 weeks postpartum.

Treatment:

Drug: Nifedipine ER

CONTROL ARM

Active Comparator group

Description:

Usual care with nifedipine ER initiation at SBP ≥150 mmHg or DBP ≥100 mmHg and maintaining blood pressure \<150/100 mmHg during the first 6 weeks postpartum.

Treatment:

Drug: Nifedipine ER