Hypertensive Disorder of Pregnancy Clinical Trial
Official title:
Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following
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 will randomize 618 postpartum patients with HDP to intensive blood pressure (BP) control with Nifedipine extended release (ER) (target BP <140/90 mmHg) versus active control group (target BP <150/100 mmHg) for 6 weeks postpartum, using home BP monitoring program at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation (FMD), arterial stiffness with carotid-femoral pulse wave velocity (cfPWV), and collection of an anti-angiogenic biomarker, soluble fms-like tyrosine kinase (sFlt-1), at baseline, 6 weeks, and 12 months postpartum. The primary outcome is the rate of new diagnosis of chronic HTN at one year postpartum. Secondary outcomes are improvement in vascular function, assessed by FMD, cfPWV, and sFlt-1, from baseline to 12 months postpartum. Sub-group analyses will be done to examine study outcomes by HDP type (gestational HTN vs. preeclampsia) and by patients that maintained BP <130/80 mmHg versus higher ;
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