Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)
Overview
- Phase
- Phase 3
- Intervention
- Nifedipine ER
- Conditions
- Hypertensive Disorder of Pregnancy
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility in recruitment
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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 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 \<150/100 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.
Investigators
Anna Palatnik, MD
Associate Professor
Medical College of Wisconsin
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Nifedipine ER
Active control arm
Active control group - a group of usual care that follows ACOG recommendations with Nifedipine initiation at SBP≥150 mmHg or DBP≥100 mm Hg and maintaining BP at \<150/100 mmHg during the first 6 weeks postpartum. In addition, participants will receive education on healthy lifestyle following AHA LE8.
Intervention: Nifedipine ER
Outcomes
Primary Outcomes
Feasibility in recruitment
Time Frame: 12 months postpartum
Number of patients successfully enrolled per month during the study.
Feasibility in retention
Time Frame: 12 months postpartum
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Feasibility in randomization
Time Frame: 12 months postpartum
Proportion of patients who enroll out of all approached, eligible patients.
Contamination
Time Frame: 12 months postpartum
Percent of patients following other antihypertensive treatment regimens.
Secondary Outcomes
- Flow-mediated dilation(12 months postpartum)
- New stage I hypertension(12 months postpartum)
- Life's Essential 8 cardiovascular health score (range 0-100)(12 months postpartum)
- Life's Simple 7 CVH (range 0-14)(12 months postpartum)
- arterial stiffness(12 months postpartum)
- Serum biomarkers of CVD risk(12 months postpartum)