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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
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| Active control arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine ER | Drug | Postpartum BP treatment to <140/90 mmHg |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert Hospital | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39395531 | Derived | Palatnik A, Sunji N, Peterson Z, Ohlendorf J, Pan AY, Kulinski J. Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy. Contemp Clin Trials. 2024 Dec;147:107710. doi: 10.1016/j.cct.2024.107710. Epub 2024 Oct 10. |
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| ID | Term |
|---|---|
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D007239 | Infections |
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| 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 |