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Hypertensive Disorder of PregnancyPhase 3IPATNCT05687344

Intensive Postpartum Antihypertensive Treatment

A Phase 3 study testing Nifedipine ER in people with Hypertensive Disorder of Pregnancy, run by Medical College of Wisconsin at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypertensive Disorder of Pregnancy
What is being tested?
Nifedipine ER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 30 Aug 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Nifedipine ER
Medical subject headings
Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nifedipine ERDrug

    Also called Tight BP control group

    Postpartum BP treatment to <140/90 mmHg

Study groups in NCT05687344
Study groupRoleWhat they receive
Intervention armExperimentalIntervention 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.
Receives: Drug: Nifedipine ER
Active control armActive comparatorActive 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.
Receives: Drug: Nifedipine ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility in randomization

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

    Measured: 12 months postpartum

  2. Feasibility in recruitment

    Number of patients successfully enrolled per month during the study.

    Measured: 12 months postpartum

  3. Feasibility in retention

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

    Measured: 12 months postpartum

  4. Contamination

    Percent of patients following other antihypertensive treatment regimens.

    Measured: 12 months postpartum

Secondary outcomes (6)

  1. New stage I hypertension

    BP of ≥130/80 mmHg

    Measured: 12 months postpartum

  2. Life's Essential 8 cardiovascular health score (range 0-100)

    The score will be calculated using American Heart Association application

    Measured: 12 months postpartum

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

    Same metrics as LE8 excluding sleep

    Measured: 12 months postpartum

  4. Flow-mediated dilation

    Brachial artery flow-mediated dilation will assess endothelial dysfunction.

    Measured: 12 months postpartum

  5. Serum biomarkers of CVD risk

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

    Measured: 12 months postpartum

  6. arterial stiffness

    Carotid-femoral pulse wave velocity will assess arterial stiffness

    Measured: 12 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Mar 2026
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687344
Sponsor's protocol ID
PRO00046214
Acronym
IPAT
Status last verified
Oct 2025
First submitted
1 Jan 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Palatnik A, Sunji N, Peterson Z, Ohlendorf J, Pan AY, Kulinski J. Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy. Contemp Clin Trials. 2024 Dec;147:107710. doi: 10.1016/j.cct.2024.107710. Epub 2024 Oct 10.

    PubMed 39395531

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nifedipine ER in people with Hypertensive Disorder of Pregnancy, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility in randomization (time frame: 12 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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