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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Postpartum BP treatment to \<140/90 mmHg
Froedtert Hospital
Milwaukee, Wisconsin, United States
Feasibility in randomization
Proportion of patients who enroll out of all approached, eligible patients.
Time frame: 12 months postpartum
Feasibility in recruitment
Number of patients successfully enrolled per month during the study.
Time frame: 12 months postpartum
Feasibility in retention
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
Time frame: 12 months postpartum
Contamination
Percent of patients following other antihypertensive treatment regimens.
Time frame: 12 months postpartum
New stage I hypertension
BP of ≥130/80 mmHg
Time frame: 12 months postpartum
Life's Essential 8 cardiovascular health score (range 0-100)
The score will be calculated using American Heart Association application
Time frame: 12 months postpartum
Life's Simple 7 CVH (range 0-14)
Same metrics as LE8 excluding sleep
Time frame: 12 months postpartum
Flow-mediated dilation
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Time frame: 12 months postpartum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Serum biomarkers of CVD risk
Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)
Time frame: 12 months postpartum
arterial stiffness
Carotid-femoral pulse wave velocity will assess arterial stiffness
Time frame: 12 months postpartum