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Home heart monitoring could stop deadly fetal heart block in its tracks

NCT ID NCT04474223

Disease control Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study tests whether pregnant women at high risk for fetal heart block can use a home monitor to catch early signs of the condition. If detected, they receive steroids and IVIG to try to reverse the block before it becomes permanent. The goal is to prevent stillbirth and the need for a lifelong pacemaker.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexamethasone and IVIG
What this could lead to
If successful, this could provide a way to detect and reverse early fetal heart block, preventing permanent damage and reducing deaths.
What could go wrong
This is an early-stage trial with a small number of participants. The treatments (steroids and IVIG) have risks, and it's not yet known if they will work or if home monitoring is reliable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2020

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Be \<18 weeks pregnant at the time of enrollment 4. Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU 5. Any positive titer of anti-Ro if a history of a previously affected child 6. Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols. 7. Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting, 8. Ability to send an audiotext message by cell phone therefore the participant will be informed that they need a phone with texting capabilities. Located within 6 hours drive of the participating pediatric cardiology site 9. Be ≥18 years of age Exclusion Criteria: 1. Multi-fetal pregnancy 2. Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency 3. Fetal conduction system disease already present in the current pregnancy 4. Any women who in the opinion of the investigator cannot understand the consent form or be able to perform thrice daily home monitoring or recognize an abnormal fetal heart rate or rhythm 5. Women prisoners 6. Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment

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Conditions

The condition(s) this trial relates to.

atrioventricular block congenital heart block

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avb - atrioventricular block Fetal avb

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Children's Hospital of Minnesota

    Minneapolis, Minnesota, 55404, United States

  • Children's National Medical Center/George Washington University

    Washington D.C., District of Columbia, 20010, United States

  • Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Eastern Virginia Medical School (EVMS)

    Norfolk, Virginia, 23507, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Perinatal Associates of New Mexico

    Rio Rancho, New Mexico, 87124, United States

  • Phoenix Children's Hospital/Dignity Health

    Phoenix, Arizona, 85016, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Stanford University

    Palo Alto, California, 94305, United States

  • Stollery Children's Hospital

    Edmonton, Alberta, AB T6G 2B7, Canada

  • UH Rainbow Babies / Children's Hospital

    Cleveland, Ohio, 44106, United States

  • University of California - Los Angeles (UCLA)

    Los Angeles, California, 90095, United States

  • University of California-San Francisco

    San Francisco, California, 94143, United States

  • University of Colorado, Denver (UCD)

    Aurora, Colorado, 80204, United States

  • University of Kentucky / Kentucky Children's Hospital

    Lexington, Kentucky, 40536, United States

  • University of Louisville / Norton Children's Hospital

    Louisville, Kentucky, 40202, United States

  • University of Michigan / C. S. Mott Children's Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Utah Health

    Salt Lake City, Utah, 84102, United States

  • University of Vermont Children's Hospital

    Burlington, Vermont, 05401, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States