Hypertensive Disorder of Pregnancy
Conditions
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.
Interventions
DRUGNifedipine ER
Postpartum BP treatment to \<140/90 mmHg
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility in randomization | 12 months postpartum | Proportion of patients who enroll out of all approached, eligible patients. |
| Feasibility in recruitment | 12 months postpartum | Number of patients successfully enrolled per month during the study. |
| Feasibility in retention | 12 months postpartum | Proportion of enrolled patients who complete all study visits during the 12 months follow-up. |
| Contamination | 12 months postpartum | Percent of patients following other antihypertensive treatment regimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New stage I hypertension | 12 months postpartum | BP of ≥130/80 mmHg |
| Life's Essential 8 cardiovascular health score (range 0-100) | 12 months postpartum | The score will be calculated using American Heart Association application |
| Life's Simple 7 CVH (range 0-14) | 12 months postpartum | Same metrics as LE8 excluding sleep |
| Flow-mediated dilation | 12 months postpartum | Brachial artery flow-mediated dilation will assess endothelial dysfunction. |
| Serum biomarkers of CVD risk | 12 months postpartum | Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1) |
| arterial stiffness | 12 months postpartum | Carotid-femoral pulse wave velocity will assess arterial stiffness |
Countries
United States
Outcome results
None listed