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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
618
Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Northwestern University
Chicago, Illinois, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGChronic hypertension
Diagnosis of chronic hypertension, defined as stage I hypertension with BP \>130/80 mmHg
Time frame: One year postpartum
Endothelial dysfunction
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Time frame: One year postpartum
Arterial stiffness
Carotid-femoral pulse wave velocity will assess arterial stiffness.
Time frame: One year postpartum
Cardiac structure and function
Transthoracic echocardiogram will assess cardiac structure and function.
Time frame: One year postpartum
Unplanned healthcare utilization
Unplanned hospital readmissions, emergency department visits, and clinic visits.
Time frame: After birth through one year postpartum
Composite severe maternal morbidity
Maternal core outcomes of preeclampsia using PMID: 32674052 reference.
Time frame: After birth through one year postpartum
Life's Essential 8 cardiovascular health score
The score (0-100) will be calculated using American Heart Association application.
Time frame: After birth through one year postpartum
Severe postpartum hypertension
Blood pressure \>160/110 mmHg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: After birth through one year postpartum
ASCVD score
Lifetime risk calculated for subjects \>20 years and 10-year risk calculated for subjects \> 40 years.
Time frame: One year postpartum