Clinical trial NCT06220721: Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
Official title: Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension, Pregnancy-Induced
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-01-24
Enrollment: 618
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: PREVENTION

Brief summary: 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.

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.

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

Primary outcomes:
measure: Chronic hypertension
timeFrame: One year postpartum
Secondary outcomes:
measure: Endothelial dysfunction
timeFrame: One year postpartum
measure: Arterial stiffness
timeFrame: One year postpartum
measure: Cardiac structure and function
timeFrame: One year postpartum
measure: Unplanned healthcare utilization
timeFrame: After birth through one year postpartum
measure: Composite severe maternal morbidity
timeFrame: After birth through one year postpartum
measure: Life's Essential 8 cardiovascular health score
timeFrame: After birth through one year postpartum
measure: Severe postpartum hypertension
timeFrame: After birth through one year postpartum
measure: ASCVD score
timeFrame: One year postpartum
Other outcomes:
measure: Serum biomarkers of cardiovascular risk
timeFrame: One year postpartum
measure: Breastfeeding initiation and duration
timeFrame: After birth through one year postpartum
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Anna Palatnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
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