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

Who is this study for? Patients with Atrioventricular Block
What treatments are being studied? Dexamethasone+IVIG
Status: Recruiting
Location: See all (36) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Be <18 weeks pregnant at the time of enrollment

• Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU

• Any positive titer of anti-Ro if a history of a previously affected child

• Ability to take oral medication and be willing to adhere to the dexamethasone and IVIG protocols.

• Ability to perform Doppler fetal heart rate and rhythm monitoring in the ambulatory setting,

• 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

• Be ≥18 years of age

Locations
United States
Arizona
Phoenix Children's Hospital
Not yet recruiting
Phoenix
California
Scripps Memorial Hospital
Not yet recruiting
La Jolla
University of California - Los Angeles (UCLA)
Not yet recruiting
Los Angeles
Stanford University
Not yet recruiting
Palo Alto
University of California-San Francisco
Not yet recruiting
San Francisco
Colorado
University of Colorado, Denver (UCD)
Not yet recruiting
Aurora
Connecticut
Yale University School of Medicine
Not yet recruiting
New Haven
Washington, D.c.
Children's National Medical Center
Not yet recruiting
Washington
Iowa
University of Iowa
Not yet recruiting
Iowa City
Illinois
Rush University Children's Hospital
Not yet recruiting
Chicago
Indiana
Riley Children's Hospital / Indiana University School of Medicine
Not yet recruiting
Indianapolis
Kentucky
University of Kentucky / Kentucky Children's Hospital
Not yet recruiting
Lexington
University of Louisville / Norton Children's Hospital
Not yet recruiting
Louisville
Maryland
Johns Hopkins Children's Center
Not yet recruiting
Baltimore
Michigan
University of Michigan / C. S. Mott Children's Hospital
Not yet recruiting
Ann Arbor
Minnesota
Children's Hospital of Minnesota
Not yet recruiting
Minneapolis
University of Minnesota
Not yet recruiting
Minneapolis
North Carolina
Duke University Medical Center
Not yet recruiting
Durham
North Dakota
Stanford Health
Not yet recruiting
Fargo
Nevada
Children's Heart Center Nevada
Not yet recruiting
Las Vegas
New York
Columbia University Medical Center
Not yet recruiting
New York
NYU Langone Health
Recruiting
New York
New York Medical College
Not yet recruiting
Valhalla
Ohio
Cleveland Clinic Lerner College of Medicine
Not yet recruiting
Cleveland
UH Rainbow Babies / Children's Hospital
Not yet recruiting
Cleveland
Oregon
Oregon Health & Science University (OHSU)
Not yet recruiting
Portland
Tennessee
Vanderbilt University Medical Center
Not yet recruiting
Nashville
Texas
Baylor College of Medicine
Not yet recruiting
Houston
University of Texas - Houston
Not yet recruiting
Houston
Utah
University of Utah Health
Not yet recruiting
Salt Lake City
Virginia
Eastern Virginia Medical School (EVMS)
Not yet recruiting
Norfolk
Vermont
University of Vermont Children's Hospital
Not yet recruiting
Burlington
Washington
Seattle Children's Hospital
Not yet recruiting
Seattle
Wisconsin
University of Wisconsin - Madison
Not yet recruiting
Madison
West Virginia
West Virginia University
Not yet recruiting
Morgantown
Other Locations
Canada
Stollery Children's Hospital
Not yet recruiting
Edmonton
Contact Information
Primary
Mala Masson
mala.masson@nyulangone.org
212-263-0372
Backup
Jill Buyon, MD
Jill.Buyon@nyulangone.org,
212-263-0756
Time Frame
Start Date: August 1, 2020
Estimated Completion Date: October 31, 2026
Participants
Target number of participants: 1300
Treatments
Experimental: Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
Authors
Jill Buyon, Shardha Srinivasan, Ruben Acherman, Shreya Sheth, Shiraz Maskatia, Nelangi Pinto, Alfred Abuhamad, James Strainic, Stephanie Levasseur, Sonal Owens, Erin Madriago, Mark Sklansky, Rukmini Komarlu, Stephen Miller, Karim Diab, Sawsan Awad, Donna Goff, Jyothi Matta, Theresa Tacy, Bhawna Arya, Lisa Hornberger, D Krakow, Arij Faksh, Deborah Friedman, Bettina Cuneo, Brian Holland, Colin Phoon, Majd Makhoul, Gary Satou, Mary Donofrio, Joshua Copel, Caitlin Haxel, Priya Sekar, Vickie Pyevich, Lisa Howley, Jimmy Lu, Anne Farrell, Ben Reinking, Stacy Stratemann-Killen, A Kean, G. Michael Siberbach, Anita Mood-Grady, A Rodenbarger, Peter Van Eerden, Elena Sinkovskaya, Christopher Lindblade, Karla Bermudez Wagner, Katherine Jacobs, Anita Krishnan, J. Philip Saul
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

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