Intensive Postpartum Antihypertensive Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)

Conditions
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Hypertensive Disorder of Pregnancy

Intervention / Treatment
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* Drug: NIFEdipine ER


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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<br>* Postpartum BP treatment to <140/90 mmHg<br>* Other names: Tight BP control group;|
| Active Comparator: Active control arm<br>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<br>* Postpartum BP treatment to <140/90 mmHg<br>* Other names: Tight BP control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility in randomization | Proportion of patients who enroll out of all approached, eligible patients. | 12 months postpartum | 
| Feasibility in recruitment | Number of patients successfully enrolled per month during the study. | 12 months postpartum | 
| Feasibility in retention | Proportion of enrolled patients who complete all study visits during the 12 months follow-up. | 12 months postpartum | 
| Contamination | Percent of patients following other antihypertensive treatment regimens. | 12 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New stage I hypertension | BP of ≥130/80 mmHg | 12 months postpartum | 
| Life's Essential 8 cardiovascular health score (range 0-100) | The score will be calculated using American Heart Association application | 12 months postpartum | 
| Life's Simple 7 CVH (range 0-14) | Same metrics as LE8 excluding sleep | 12 months postpartum | 
| Flow-mediated dilation | Brachial artery flow-mediated dilation will assess endothelial dysfunction. | 12 months postpartum | 
| Serum biomarkers of CVD risk | Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1) | 12 months postpartum | 
| arterial stiffness | Carotid-femoral pulse wave velocity will assess arterial stiffness | 12 months postpartum |