Intensive Postpartum Antihypertensive Treatment

Phase 3

Recruiting

• Conditions: Hypertensive Disorder of Pregnancy
• Interventions: Drug: Nifedipine ER

• Registration Number: NCT05687344
• Lead Sponsor: Medical College of Wisconsin

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.

Study Timeline

• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-18
• Study Start: 2023-09-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Nifedipine ER	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.
Active control arm	Nifedipine ER	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.

Primary Outcome Measures

Name	Time	Method
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.
Feasibility in randomization	12 months postpartum	Proportion of patients who enroll out of all approached, eligible patients.
Contamination	12 months postpartum	Percent of patients following other antihypertensive treatment regimens.

Secondary Outcome Measures

Name	Time	Method
Flow-mediated dilation	12 months postpartum	Brachial artery flow-mediated dilation will assess endothelial dysfunction.
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
arterial stiffness	12 months postpartum	Carotid-femoral pulse wave velocity will assess arterial stiffness
Serum biomarkers of CVD risk	12 months postpartum	Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)

Trial Locations

Locations (1)

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States