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NCT04474223 · ClinicalTrials.gov registry record · Phase 3
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)
A Phase 3 study of AVB - Atrioventricular Block and Fetal AVB, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,300
- Enrollment target
- 20
- Study locations
NCT04474223 is a Phase 3 study of AVB - Atrioventricular Block and Fetal AVB that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 1,300 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT04474223, a Phase 3 study of AVB - Atrioventricular Block and Fetal AVB, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,300 participants
- Enrollment target
- 20
- Study locations
Study Summary
Fetal complete (i.e., third degree, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB has been ineffective in restoring normal rhythm (NR) which may be because current surveillance is limited to once- weekly fetal echocardiograms. It is hypothesized that there may be a vital transition period of several hours in which incomplete block (2° AVB) may be successfully treated avoiding fully advanced irreversible 3° AVB. To optimize the likelihood of timely detection of the transition period this study comprises three steps: 1) to risk stratify for high titer anti-Ro antibodies, which are necessary but not sufficient to develop fetal AVB; 2) to empower mothers to identify 2° AVB by using fetal heart rate and rhythm monitoring (FHRM) at home, and 3) to rapidly treat mothers who detect an abnormality by monitoring with an urgent echocardiogram that confirms 2° AVB with the hope of reversing 2° AVB before it becomes permanent (3° AVB). In addition, it will be determined if FHRM reduces the need for weekly echoes. Although mothers with low titer anti-Ro will not be continued in Step 2 and therefore not followed by FHRM, birth ECGs will be collected to confirm that low titer antibodies do not confer risk. It is anticipated that this study will provide an evidenced based surveillance strategy for those mothers at high risk of having a child with 3° AVB.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG IVIG
Study Locations (20)
California
- University of California - Los Angeles (UCLA) - Los Angeles
- Stanford University - Palo Alto
- University of California-San Francisco - San Francisco
New York
- NYU Langone Health - New York
- Mount Sinai - New York
- Columbia University Medical Center - New York
Kentucky
- University of Kentucky / Kentucky Children's Hospital - Lexington
- University of Louisville / Norton Children's Hospital - Louisville
Ohio
- UH Rainbow Babies / Children's Hospital - Cleveland
- Cleveland Clinic Lerner College of Medicine - Cleveland
Arizona
- Phoenix Children's Hospital/Dignity Health - Phoenix
Colorado
- University of Colorado, Denver (UCD) - Aurora
Connecticut
- Yale University School of Medicine - New Haven
District of Columbia
- Children's National Medical Center/George Washington University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2020-08-01 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04474223
The ClinicalTrials.gov registry entry for NCT04474223 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with AVB - Atrioventricular Block appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT04474223 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04474223 about?
NCT04474223 is a clinical study titled "Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)". Fetal complete (i.e., third degree, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB ha...
What is the current status of trial NCT04474223?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,300 participants. The study started on 2020-08-01. Estimated completion is 2029-06-30.
What conditions does trial NCT04474223 study?
This clinical trial studies the following conditions: AVB - Atrioventricular Block, Fetal AVB.
What interventions are being tested in trial NCT04474223?
The interventions under investigation include: Dexamethasone (DRUG), IVIG (DRUG).
Who is sponsoring clinical trial NCT04474223?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04474223 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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