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OpenTrials
Active, Not Recruiting

NCT Number: NCT05687344

Intensive Postpartum Antihypertensive Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NIFEdipine ER

Drug

Postpartum BP treatment to <140/90 mmHg

Other names: Tight BP control group

Primary outcomes

  1. Feasibility in randomization

    Time frame: 12 months postpartum

    Proportion of patients who enroll out of all approached, eligible patients.

  2. Feasibility in recruitment

    Time frame: 12 months postpartum

    Number of patients successfully enrolled per month during the study.

  3. Feasibility in retention

    Time frame: 12 months postpartum

    Proportion of enrolled patients who complete all study visits during the 12 months follow-up.

  4. Contamination

    Time frame: 12 months postpartum

    Percent of patients following other antihypertensive treatment regimens.

Secondary outcomes

  1. New stage I hypertension

    Time frame: 12 months postpartum

    BP of ≥130/80 mmHg

  2. 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

  3. Life's Simple 7 CVH (range 0-14)

    Time frame: 12 months postpartum

    Same metrics as LE8 excluding sleep

  4. Flow-mediated dilation

    Time frame: 12 months postpartum

    Brachial artery flow-mediated dilation will assess endothelial dysfunction.

  5. Serum biomarkers of CVD risk

    Time frame: 12 months postpartum

    Anti-angiogenic marker: Soluble fms-like tyrosine kinase (sFlt-1)

  6. arterial stiffness

    Time frame: 12 months postpartum

    Carotid-femoral pulse wave velocity will assess arterial stiffness

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

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

Acronym: IPAT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2023
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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