Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
- Registration Number
- NCT06220721
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 618
- Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
- Postpartum day 0-4
- Age ≥ 18 years
- 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.
- 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
- Already taking long-acting antihypertensive medication for standard care
- Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REPAIR ARM Nifedipine ER 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. CONTROL ARM Nifedipine ER 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.
- Primary Outcome Measures
Name Time Method Chronic hypertension One year postpartum Diagnosis of chronic hypertension, defined as stage I hypertension with BP \>130/80 mmHg
- Secondary Outcome Measures
Name Time Method Unplanned healthcare utilization After birth through one year postpartum Unplanned hospital readmissions, emergency department visits, and clinic visits.
Composite severe maternal morbidity After birth through one year postpartum Maternal core outcomes of preeclampsia using PMID: 32674052 reference.
Arterial stiffness One year postpartum Carotid-femoral pulse wave velocity will assess arterial stiffness.
Endothelial dysfunction One year postpartum Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Cardiac structure and function One year postpartum Transthoracic echocardiogram will assess cardiac structure and function.
Life's Essential 8 cardiovascular health score After birth through one year postpartum The score (0-100) will be calculated using American Heart Association application.
ASCVD score One year postpartum Lifetime risk calculated for subjects \>20 years and 10-year risk calculated for subjects \> 40 years.
Severe postpartum hypertension After birth through one year postpartum Blood pressure \>160/110 mmHg
Trial Locations
- Locations (2)
Northwestern University
🇺🇸Chicago, Illinois, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States