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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMedical College of Wisconsin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nifedipine ER

    Drug

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

Treatment groups

618 Participants
are divided into 2 treatment groups
Group A: REPAIR ARMExperimental treatment 1 intervention
Group B: CONTROL ARMActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Chronic hypertension

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

Time frame
One year postpartum

Secondary outcomes

1

Endothelial dysfunction

Brachial artery flow-mediated dilation will assess endothelial dysfunction.

Time frame
One year postpartum
2

Arterial stiffness

Carotid-femoral pulse wave velocity will assess arterial stiffness.

Time frame
One year postpartum
3

Cardiac structure and function

Transthoracic echocardiogram will assess cardiac structure and function.

Time frame
One year postpartum
4

Unplanned healthcare utilization

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

Time frame
After birth through one year postpartum

Other outcomes

1

Serum biomarkers of cardiovascular risk

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

Time frame
One year postpartum
2

Breastfeeding initiation and duration

Assessed with Infant Feeding Practices Postnatal Questionnaires

Time frame
After birth through one year postpartum

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical College of Wisconsin

Lead sponsor

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

Collaborator