RECRUITING

Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

Quick Facts

Study Start:2020-08-01
Study Completion:2026-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04474223

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. 3. Be \<18 weeks pregnant at the time of enrollment
  4. 4. Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU
  5. 5. Any positive titer of anti-Ro if a history of a previously affected child
  6. 6. Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.
  7. 7. Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,
  8. 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. 9. Be ≥18 years of age
  1. 1. Multi-fetal pregnancy
  2. 2. Known allergic reactions to components of IVIG, or dexamethasone or maternal IgA deficiency
  3. 3. Fetal conduction system disease already present in the current pregnancy
  4. 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. 5. Women prisoners
  6. 6. Treatment with \>20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment

Contacts and Locations

Study Contact

Mala Masson
CONTACT
212-263-0372
mala.masson@nyulangone.org
Jill Buyon, MD
CONTACT
212-263-0756
Jill.Buyon@nyulangone.org,

Principal Investigator

Jill Buyon, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Bettina Cuneo, MD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

Phoenix Children's Hospital/Dignity Health
Phoenix, Arizona, 85016
United States
University of California - Los Angeles (UCLA)
Los Angeles, California, 90095
United States
Stanford University
Palo Alto, California, 94305
United States
University of California-San Francisco
San Francisco, California, 94143
United States
University of Colorado, Denver (UCD)
Aurora, Colorado, 80204
United States
Yale University School of Medicine
New Haven, Connecticut, 06510
United States
Children's National Medical Center/George Washington University
Washington, District of Columbia, 20010
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
Children's Hospital of Minnesota
Minneapolis, Minnesota, 55404
United States
Perinatal Associates of New Mexico
Rio Rancho, New Mexico, 87124
United States
NYU Langone Health
New York, New York, 10016
United States
Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
UH Rainbow Babies / Children's Hospital
Cleveland, Ohio, 44106
United States
Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44195
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
University of Utah Health
Salt Lake City, Utah, 84102
United States
University of Vermont Children's Hospital
Burlington, Vermont, 05401
United States
Eastern Virginia Medical School (EVMS)
Norfolk, Virginia, 23507
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Jill Buyon, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Bettina Cuneo, MD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

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 Registration Dates

Study Start Date2020-08-01
Study Completion Date2026-10-31

Study Record Updates

Study Start Date2020-08-01
Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • AVB - Atrioventricular Block
  • Fetal AVB