Intensive Postpartum Antihypertensive Treatment

Hypertensive Disorder of Pregnancy Clinical Trial

— IPAT  

Official title:

Intensive Postpartum Antihypertensive Treatment to Improve Women's Cardiovascular Health (IPAT Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687344
• Other study ID #: PRO00046214
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2023
• Est. completion date: March 2026

Study information

• Verified date: January 2024
• Source: Medical College of Wisconsin
• Contact: Anna Palatnik, MD
• Phone: 4148056627
• Email: apalatnik[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 <160/110 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Disorder of Pregnancy
• Toxemia

Intervention

Drug:
• Nifedipine ER
Postpartum BP treatment to <140/90 mmHg

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility in randomization	Proportion of patients who enroll out of all approached, eligible patients.	12 months postpartum
Primary	Feasibility in recruitment	Number of patients successfully enrolled per month during the study.	12 months postpartum
Primary	Feasibility in retention	Proportion of enrolled patients who complete all study visits during the 12 months follow-up.	12 months postpartum
Primary	Contamination	Percent of patients following other antihypertensive treatment regimens.	12 months postpartum
Secondary	New stage I hypertension	BP of =130/80 mmHg	12 months postpartum
Secondary	Life's Essential 8 cardiovascular health score (range 0-100)	The score will be calculated using American Heart Association application	12 months postpartum
Secondary	Life's Simple 7 CVH (range 0-14)	Same metrics as LE8 excluding sleep	12 months postpartum
Secondary	Flow-mediated dilation	Brachial artery flow-mediated dilation will assess endothelial dysfunction.	12 months postpartum
Secondary	Serum biomarkers of CVD risk	Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)	12 months postpartum
Secondary	arterial stiffness	Carotid-femoral pulse wave velocity will assess arterial stiffness	12 months postpartum