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

May 7, 2025 updated by: Anna Palatnik, MD, Medical College of Wisconsin
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

618

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Lynn Yee, MD
        • Contact:
        • Sub-Investigator:
          • Sadiya Khan, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Principal Investigator:
          • Anna Palatnik, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jacquelyn Kulinski, MD
        • Sub-Investigator:
          • Amy Pan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Nifedipine ER
Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Other Names:
  • Procardia XL
  • Adalat XL
Active Comparator: 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.
Drug: Nifedipine ER
Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Other Names:
  • Procardia XL
  • Adalat XL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic hypertension
Time Frame: One year postpartum
Diagnosis of chronic hypertension, defined as stage I hypertension with BP >130/80 mmHg
One year postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial dysfunction
Time Frame: One year postpartum
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
One year postpartum
Arterial stiffness
Time Frame: One year postpartum
Carotid-femoral pulse wave velocity will assess arterial stiffness.
One year postpartum
Cardiac structure and function
Time Frame: One year postpartum
Transthoracic echocardiogram will assess cardiac structure and function.
One year postpartum
Unplanned healthcare utilization
Time Frame: After birth through one year postpartum
Unplanned hospital readmissions, emergency department visits, and clinic visits.
After birth through one year postpartum
Composite severe maternal morbidity
Time Frame: After birth through one year postpartum
Maternal core outcomes of preeclampsia using PMID: 32674052 reference.
After birth through one year postpartum
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.
After birth through one year postpartum
Severe postpartum hypertension
Time Frame: After birth through one year postpartum
Blood pressure >160/110 mmHg
After birth through one year postpartum
ASCVD score
Time Frame: One year postpartum
Lifetime risk calculated for subjects >20 years and 10-year risk calculated for subjects > 40 years.
One year postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding initiation and duration
Time Frame: After birth through one year postpartum
Assessed with Infant Feeding Practices Postnatal Questionnaires
After birth through one year postpartum
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
One year postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

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

Investigators

  • Principal Investigator: Anna Palatnik, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00049909
  • 1R01HD112930-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After study closure, data will be deidentified, archived, and transmitted to the NICHD Data Specimen and Hub (DASH). Permission to transmit and store the data in DASH is included in the informed consent document.

IPD Sharing Time Frame

Anticipated 6/30/2030

IPD Sharing Access Criteria

The NICHD DASH Data Access Committee reviews all requests to access DASH data and biospecimens from identity-verified requesters to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data or biospecimens.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension, Pregnancy-Induced

Clinical Trials on Nifedipine ER

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe