Trials / Recruiting
RecruitingNCT06220721
Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 618 (estimated)
- Sponsor
- Medical College of Wisconsin · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nifedipine ER | Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum. |
Timeline
- Start date
- 2024-10-23
- Primary completion
- 2029-03-31
- Completion
- 2029-06-30
- First posted
- 2024-01-24
- Last updated
- 2025-05-11
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06220721. Inclusion in this directory is not an endorsement.