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NCT Number: NCT06220721

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIFEdipine ER

Drug

Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.

Other names: Procardia XL, Adalat XL

Primary outcomes

  1. Chronic hypertension

    Time frame: One year postpartum

    Diagnosis of chronic hypertension, defined as stage I hypertension with BP >130/80 mmHg

Secondary outcomes

  1. Endothelial dysfunction

    Time frame: One year postpartum

    Brachial artery flow-mediated dilation will assess endothelial dysfunction.

  2. Arterial stiffness

    Time frame: One year postpartum

    Carotid-femoral pulse wave velocity will assess arterial stiffness.

  3. Cardiac structure and function

    Time frame: One year postpartum

    Transthoracic echocardiogram will assess cardiac structure and function.

  4. Unplanned healthcare utilization

    Time frame: After birth through one year postpartum

    Unplanned hospital readmissions, emergency department visits, and clinic visits.

  5. Composite severe maternal morbidity

    Time frame: After birth through one year postpartum

    Maternal core outcomes of preeclampsia using PMID: 32674052 reference.

  6. Life's Essential 8 cardiovascular health score

    Time frame: After birth through one year postpartum

    The score (0-100) will be calculated using American Heart Association application.

  7. Severe postpartum hypertension

    Time frame: After birth through one year postpartum

    Blood pressure >160/110 mmHg

  8. ASCVD score

    Time frame: One year postpartum

    Lifetime risk calculated for subjects >20 years and 10-year risk calculated for subjects > 40 years.

Other outcomes

  1. Serum biomarkers of cardiovascular risk

    Time frame: One year postpartum

    Soluble fms-like tyrosine kinase (sFlt-1), Lipoprotein (a), TNF-alpha, IL-6, NT-proBNP, CRP, high-sensitivity troponin

  2. Breastfeeding initiation and duration

    Time frame: After birth through one year postpartum

    Assessed with Infant Feeding Practices Postnatal Questionnaires

Study contacts

Contact information is provided by the study sponsor or research team.

Alyssa M Hernandez, DO

CONTACT

[email protected]

4148055285

Amandla Stanley, MSN

CONTACT

[email protected]

4148056691

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: REPAIR

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 24, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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