Intensive Postpartum Antihypertensive Treatment (IPAT)

October 21, 2025 updated by: Anna Palatnik, MD, Medical College of Wisconsin

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
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.
Drug: Nifedipine ER
Postpartum BP treatment to <140/90 mmHg
Other Names:
  • Tight BP control group
Active Comparator: Active control arm
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.
Drug: Nifedipine ER
Postpartum BP treatment to <140/90 mmHg
Other Names:
  • Tight BP control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility in randomization
Time Frame: 12 months postpartum
Proportion of patients who enroll out of all approached, eligible patients.
12 months postpartum
Feasibility in recruitment
Time Frame: 12 months postpartum
Number of patients successfully enrolled per month during the study.
12 months postpartum
Feasibility in retention
Time Frame: 12 months postpartum
Proportion of enrolled patients who complete all study visits during the 12 months follow-up.
12 months postpartum
Contamination
Time Frame: 12 months postpartum
Percent of patients following other antihypertensive treatment regimens.
12 months postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New stage I hypertension
Time Frame: 12 months postpartum
BP of ≥130/80 mmHg
12 months postpartum
Life's Essential 8 cardiovascular health score (range 0-100)
Time Frame: 12 months postpartum
The score will be calculated using American Heart Association application
12 months postpartum
Life's Simple 7 CVH (range 0-14)
Time Frame: 12 months postpartum
Same metrics as LE8 excluding sleep
12 months postpartum
Flow-mediated dilation
Time Frame: 12 months postpartum
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
12 months postpartum
Serum biomarkers of CVD risk
Time Frame: 12 months postpartum
Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)
12 months postpartum
arterial stiffness
Time Frame: 12 months postpartum
Carotid-femoral pulse wave velocity will assess arterial stiffness
12 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 1, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Estimated)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00046214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertensive Disorder of Pregnancy

Clinical Trials on Nifedipine ER

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe