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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Medical College of Wisconsin
Study ID
NCT06220721
Status
Recruiting

Conditions

  • Hypertension, Pregnancy-Induced

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nifedipine ER — DRUG
    Initiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
May 2025
Primary completion
Mar 31, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
618 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.

Primary Outcome Measure

Chronic hypertension [ Time Frame: One year postpartum ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Lynn Yee, MD
Lynn Yee, MD (PRINCIPAL_INVESTIGATOR)
Sadiya Khan, MD (SUB_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Alyssa M Hernandez, DO
4148055285
Amandla Stanley, MSN
4148056691
Anna Palatnik, MD (PRINCIPAL_INVESTIGATOR)
Jacquelyn Kulinski, MD (SUB_INVESTIGATOR)
Amy Pan, PhD (SUB_INVESTIGATOR)

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