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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor: NYU Langone Health
Study ID: NCT04474223
Phase: PHASE3
Status: Recruiting

Apply to this trial

Conditions

AVB - Atrioventricular Block
Fetal AVB

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Dexamethasone — DRUG
In mother in whom 2° AVB or AV interval \>170 ms has been diagnosed in the fetus: Dexamethasone 8 mg po/day for 10 days. Then dexamethasone 4 mg po/ day through 28 weeks 6 days gestational age (GA); then 3 mg/day from 29 wks 0 days to 29 wks 6 days GA; then 2 mg/day until delivery
IVIG — DRUG
In a mother in whom 2° AVB has been diagnosed in the fetus: One dose of IVIG \[1g/kg of maternal weight (max dose 70 g)\] at diagnosis of 2° AVB (within 12 hours of detection by mother via home monitoring and within 6 hours of confirmation by echocardiogram). A fetal AV interval \> 170 ms will not be treated with maternal IVIG, only dexamethasone.

Study Details

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.

Key Dates

Start date: Aug 1, 2020
Status verified: Mar 2026
Primary completion: Dec 31, 2028
Completion: Jun 30, 2029

Study Design

Enrollment: 1,300 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms

Primary Outcome Measure

Percentage of 2° AVB subjects with NR (1:1 AV conduction) at birth [ Time Frame: up to 25 weeks post-enrollment ]

Central Contacts

Mala Masson
212-263-0372
[email protected]
Jill Buyon, MD
212-263-0756
[email protected],

Locations (23)

Facility	City	State	ZIP	Site coordinators
Phoenix Children's Hospital/Dignity Health	Phoenix	Arizona	85016	Christopher Lindblade, MD [email protected] Christopher Lindblade, MD (PRINCIPAL_INVESTIGATOR)
University of California - Los Angeles (UCLA)	Los Angeles	California	90095	Gary Satou, MD [email protected] Mark Sklansky, MD [email protected] Gary Satou, MD (PRINCIPAL_INVESTIGATOR) Mark Sklansky, MD (SUB_INVESTIGATOR) D Krakow, MD (SUB_INVESTIGATOR)
Stanford University	Palo Alto	California	94305	Theresa Tacy, MD [email protected] Michelle Kaplinski, MD [email protected] Theresa Tacy, MD (PRINCIPAL_INVESTIGATOR) Michelle Kaplinski, MD (SUB_INVESTIGATOR)
University of California-San Francisco	San Francisco	California	94143	Anita Mood-Grady, MD [email protected] Anita Mood-Grady, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado, Denver (UCD)	Aurora	Colorado	80204	Bettina Cuneo, MD [email protected] 720-777-1030 Bettina Cuneo, MD (PRINCIPAL_INVESTIGATOR)
Yale University School of Medicine	New Haven	Connecticut	06510	Joshua Copel, MD [email protected] Joshua Copel, MD (PRINCIPAL_INVESTIGATOR)
Children's National Medical Center/George Washington University	Washington D.C.	District of Columbia	20010	Anita Krishnan, MD [email protected] Mary Donofrio, MD [email protected] Anita Krishnan, MD (PRINCIPAL_INVESTIGATOR) Mary Donofrio, MD (SUB_INVESTIGATOR)
University of Kentucky / Kentucky Children's Hospital	Lexington	Kentucky	40536	Kristopher Cumbermack, MD [email protected] Kristopher Cumbermack, MD (PRINCIPAL_INVESTIGATOR)
University of Louisville / Norton Children's Hospital	Louisville	Kentucky	40202	Jyothi Matta, MBBS [email protected] Brian Holland, MD [email protected] Jyothi Matta, MBBS (PRINCIPAL_INVESTIGATOR) Brian Holland, MD (SUB_INVESTIGATOR)
University of Michigan / C. S. Mott Children's Hospital	Ann Arbor	Michigan	48109	Sonal Owens, MD [email protected] Sonal Owens, MD (PRINCIPAL_INVESTIGATOR) Jimmy Lu, MD (SUB_INVESTIGATOR)
Children's Hospital of Minnesota	Minneapolis	Minnesota	55404	Lisa Howley, MD [email protected] Lisa Howley, MD (PRINCIPAL_INVESTIGATOR)
Perinatal Associates of New Mexico	Rio Rancho	New Mexico	87124	Gary Joffe, MD [email protected] Gary Joffe, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical Center	New York	New York	10032	Stephanie Levasseur, MD [email protected] Stephanie Levasseur, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai	New York	New York	10029	Erin Paul, MD [email protected] Erin Paul, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Health	New York	New York	10016	Colin Phoon, MD [email protected] Jill Buyon, MD (PRINCIPAL_INVESTIGATOR) Colin Phoon, MD (SUB_INVESTIGATOR)
Cleveland Clinic Lerner College of Medicine	Cleveland	Ohio	44195	Rukmini Komarlu, MD [email protected] Rukmini Komarlu, MD (PRINCIPAL_INVESTIGATOR)
UH Rainbow Babies / Children's Hospital	Cleveland	Ohio	44106	James Strainic, MD [email protected] James Strainic, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical Center	Nashville	Tennessee	37232	Stacy Stratemann-Killen, MD [email protected] Stacy Stratemann-Killen, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine	Houston	Texas	77030	Tam Doan, MD [email protected] Tam Doan, MD (PRINCIPAL_INVESTIGATOR) Shreya Sheth, MD (SUB_INVESTIGATOR)
University of Utah Health	Salt Lake City	Utah	84102	Whitnee Hogan, MD [email protected] Whitnee Hogan, MD (PRINCIPAL_INVESTIGATOR)
University of Vermont Children's Hospital	Burlington	Vermont	05401	Caitlin Haxel, MD [email protected] Caitlin Haxel, MD (PRINCIPAL_INVESTIGATOR)
Eastern Virginia Medical School (EVMS)	Norfolk	Virginia	23507	Elena Sinkovskaya, MD [email protected] Alfred Abuhamad, MD [email protected] Elena Sinkovskaya, MD (PRINCIPAL_INVESTIGATOR) Alfred Abuhamad, MD (SUB_INVESTIGATOR)
Seattle Children's Hospital	Seattle	Washington	98105	Bhawna Arya, MD [email protected] Bhawna Arya, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site

Phoenix Children's Hospital/Dignity Health· Phoenix, AZ University of California - Los Angeles (UCLA)· Los Angeles, CA Stanford University· Palo Alto, CA University of California-San Francisco· San Francisco, CA University of Colorado, Denver (UCD)· Aurora, CO Yale University School of Medicine· New Haven, CT