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IPAT: Intensive Postpartum Antihypertensive Treatment

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687344
Collaborator
(none)
60
Enrollment
2
Arms
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: NIFEdipine ER
 Phase 3

Detailed Description

The IPAT will randomize 60 postpartum patients with HDP at the Medical College of Wisconsin (MCW) to intensive BP control with Nifedipine extended release (ER) (target BP <140/90 mmHg) versus usual care (target BP <160/110 mmHg). Oversampling of Black patients with HDP will be done to ensure they comprise 50% of study participants. Patients enrolled in both arms will undergo education on healthy lifestyle following AHA "Life's Essential 8" (LE8) of tobacco cessation, physical activity, healthy sleep, and healthy diet with detailed overview of DASH throughout the first year postpartum with monthly virtual educational session delivered by a registered dietician and a life coach. Assessment of LE8 CVH score will be done after delivery, 6 weeks postpartum, and 12 months postpartum. Participants will also undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation (FMD), arterial stiffness with carotid-femoral pulse wave velocity (cfPWV) and anti-angiogenic and inflammatory CVD biomarker with soluble fms-like tyrosine kinase (sFlt-1), at baseline, 6 weeks, and 12 months postpartum. The primary outcome is feasibility of all study procedures, including recruitment, retention, and adherence. Secondary outcomes are change in BP, CVH score, FMD, PWV, and sFlt-1 from baseline to 12 months postpartum.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention arm

Intervention group - intensive postpartum BP control with Nifedipine initiation at SBP≥140 mmHg or DBP≥90 mmHg and maintaining BP at <140/90 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

Drug: NIFEdipine ER
Postpartum BP treatment to <140/90 mmHg
Other Names:
  • Tight BP control group

    		•
    Active Comparator: Active control arm

    Active control group - a group of usual care that follows ACOG recommendations2 with Nifedipine initiation at SBP≥160 mmHg or DBP≥110 mm Hg and maintaining BP at <160/110 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.

    Drug: NIFEdipine ER
    Postpartum BP treatment to <140/90 mmHg
    Other Names:
  • Tight BP control group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility in randomization [12 months postpartum]

      Proportion of patients who enroll out of all approached, eligible patients.

    2. Feasibility in recruitment [12 months postpartum]

      Number of patients successfully enrolled per month during the study.

    3. Feasibility in retention [12 months postpartum]

      Proportion of enrolled patients who complete all study visits during the 12 months follow-up.

    4. Contamination [12 months postpartum]

      Percent of patients following other antihypertensive treatment regimens.

    Secondary Outcome Measures

    1. New stage I hypertension [12 months postpartum]

      BP of ≥130/80 mmHg

    2. Life's Essential 8 cardiovascular health score (range 0-100) [12 months postpartum]

      The score will be calculated using American Heart Association application

    3. Life's Simple 7 CVH (range 0-14) [12 months postpartum]

      Same metrics as LE8 excluding sleep

    4. Flow-mediated dilation [12 months postpartum]

      Brachial artery flow-mediated dilation will assess endothelial dysfunction.

    5. Serum biomarkers of CVD risk [12 months postpartum]

      Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)

    6. arterial stiffness [12 months postpartum]

      Carotid-femoral pulse wave velocity will assess arterial stiffness

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • HDP diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines

    • Postpartum day 0-3 and prior to discharge

    • Able to communicate in English or in Spanish

    • Age 18 - 45

    Exclusion Criteria:

    • Pre-gestational hypertension

    • Pre-gestational diabetes ( type 1 or type 2)

    • Intent to transfer postpartum to an outside institution of the participating centers

    • Known allergy to nifedipine or other significant contraindication to nifedipine

    • Inability or unwillingness to provide informed consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anna Palatnik, MD, Associate Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT05687344
    Other Study ID Numbers:
    • PRO00046214
    First Posted:
    Jan 18, 2023
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Jan 1, 2023
    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
    Additional relevant MeSH terms:
    Toxemia
    Hypertension
    Nifedipine

    Study Results

    No Results Posted as of Jan 18, 2023