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Recruiting

Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia

NCT06220721 · Medical College of Wisconsin
In plain English

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About this study
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.
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
Study design
Enrollment target: 618 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-23
Estimated completion: 2029-06-30
Last updated: 2025-05-11
Interventions
Drug: Nifedipine ER
Primary outcomes
  • Chronic hypertension (One year postpartum)
Sponsor
Medical College of Wisconsin · other
With: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contacts & investigators
ContactAlyssa M Hernandez, DO · contact · alyhernandez@mcw.edu · 4148055285
ContactAmandla Stanley, MSN · contact · akstanley@mcw.edu · 4148056691
InvestigatorAnna Palatnik, MD · principal_investigator, Medical College of Wisconsin
All locations (2)
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia · TrialPath