Intensive Postpartum Antihypertensive Treatment (IPAT)

Medical College of Wisconsin

Status and phase: Active, not recruiting; Phase 3

Conditions: Hypertensive Disorder of Pregnancy

Treatments: Drug: Nifedipine ER

Study type: Interventional

Funder types: Other

Identifiers

NCT05687344

PRO00046214

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Drug: Nifedipine ER

Active control arm

Active Comparator group

Description:

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.

Treatment:

Drug: Nifedipine ER