Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
Overview
- Phase
- Phase 4
- Intervention
- Nifedipine ER
- Conditions
- Hypertension, Pregnancy-Induced
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 618
- Locations
- 2
- Primary Endpoint
- Chronic hypertension
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
Inclusion Criteria
- •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.
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
- •Already taking long-acting antihypertensive medication for standard care
- •Maternal conditions that impact study outcomes: sickle cell disease, systemic lupus erythematosus
Arms & Interventions
REPAIR ARM
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.
Intervention: Nifedipine ER
CONTROL ARM
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.
Intervention: Nifedipine ER
Outcomes
Primary Outcomes
Chronic hypertension
Time Frame: One year postpartum
Diagnosis of chronic hypertension, defined as stage I hypertension with BP \>130/80 mmHg
Secondary Outcomes
- Unplanned healthcare utilization(After birth through one year postpartum)
- Composite severe maternal morbidity(After birth through one year postpartum)
- Arterial stiffness(One year postpartum)
- Endothelial dysfunction(One year postpartum)
- Cardiac structure and function(One year postpartum)
- Life's Essential 8 cardiovascular health score(After birth through one year postpartum)
- ASCVD score(One year postpartum)
- Severe postpartum hypertension(After birth through one year postpartum)