Your session is about to expire
← Back to Search
Corticosteroid
Dexamethasone + IVIG for Fetal AV Block
Phase 3
Recruiting
Led By Jill Buyon, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Located within 6 hours drive of the participating pediatric cardiology site
Be <18 weeks pregnant at the time of enrollment
Must not have
Treatment with >20 mg/prednisone q day or with any dose of fluorinated steroids at enrollment
Women prisoners
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-birth
Awards & highlights
Summary
This trial involves pregnant women using a home device to monitor their baby's heart. If they detect any heart issues, they get a quick follow-up test at the hospital. The goal is to catch and treat heart issues early before they become serious.
Who is the study for?
This trial is for pregnant women over 18 with high levels of anti-Ro antibodies, which are linked to fetal heart block. They must be able to monitor the baby's heart rate at home, send audio texts, live within a 6-hour drive of the cardiology site, and take oral medication. It excludes those with multi-fetal pregnancies or known allergies to the study drugs.
What is being tested?
The STOP BLOQ trial tests if early detection and treatment can prevent severe fetal atrioventricular block in babies whose mothers have specific autoantibodies. It involves risk assessment, home monitoring by mothers, and rapid treatment with Dexamethasone or IVIG upon detecting abnormalities.
What are the potential side effects?
Dexamethasone may cause increased blood sugar levels, mood changes, stomach ulcers or increased appetite. IVIG might lead to mild flu-like symptoms such as fever or muscle aches; more rarely it could cause allergic reactions or impact kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I live within a 6-hour drive of the pediatric cardiology site.
Select...
I am less than 18 weeks pregnant.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking more than 20 mg of prednisone or any dose of fluorinated steroids currently.
Select...
I am a woman currently incarcerated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-birth
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of 2° AVB subjects with NR (1:1 AV conduction) at birth
Secondary study objectives
Incidences of isolated extra-nodal cardiac disease
Percentage of 2° AVB subjects who maintain NR at age 1 year.
Percentage of AV interval > 170 msec subjects with NR at birth
Side effects data
From 2020 Phase 3 trial • 105 Patients • NCT0306524417%
Continued Fever after treatment completion and crossover to other study treatment
15%
Fever following crossover treatment
15%
Fever after discharge not attributed to KD
6%
GI Symptoms
4%
Rash
4%
Arthritis/pain and swelling in extremities
4%
Epistaxis
2%
Leukemoid Reaction
2%
Hemolytic Anemia
2%
Hyperhidrosis
2%
Dress Syndrome
2%
Pancreatitis
2%
URI
2%
Chest Pain
2%
Color Blindness
2%
Headache
2%
Pain (IV Site)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
IVIG
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mothers with Fetuses Who Have 2° AVB or AV interval > 170msExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
IVIG
2016
Completed Phase 4
~2970
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Atrioventricular Block (AVB) include sympathomimetic drugs and corticosteroids. Sympathomimetic drugs, such as isoproterenol, work by stimulating beta-adrenergic receptors to increase heart rate, which is essential in managing bradycardia associated with AVB.
Corticosteroids like dexamethasone may not directly affect the heart rate or AV block but can improve the clinical tolerance of conduction disturbances. These treatments are vital for AVB patients as they help maintain an adequate heart rate and prevent the progression of the block, thereby reducing the risk of severe complications and improving patient outcomes.
[Use of sympathomimetic agents in fetal atrioventricular heart block].[Use of high doses of atropine during dipyridamole echocardiography: safety and efficacy of the combined test].Ivabradine for chronic heart rate control in persistent atrial fibrillation. Design of the BRAKE-AF project.
[Use of sympathomimetic agents in fetal atrioventricular heart block].[Use of high doses of atropine during dipyridamole echocardiography: safety and efficacy of the combined test].Ivabradine for chronic heart rate control in persistent atrial fibrillation. Design of the BRAKE-AF project.
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,398 Previous Clinical Trials
860,350 Total Patients Enrolled
Jill Buyon, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
307 Total Patients Enrolled
Bettina Cuneo, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I live within a 6-hour drive of the pediatric cardiology site.I can have my baby's heart rate and rhythm checked with a Doppler outside of the hospital.You have a high level of anti-Ro 52 or 60 antibodies in your blood.I can take pills and follow the treatment plan for dexamethasone and IVIG.I am less than 18 weeks pregnant.You have a positive anti-Ro titer and have had a child affected by this in the past.I am not taking more than 20 mg of prednisone or any dose of fluorinated steroids currently.I am 18 years old or older.I am a woman currently incarcerated.The fetus already has a heart condition in the current pregnancy.You are pregnant with more than one baby.You are allergic to the ingredients in IVIG or dexamethasone, or have a specific immune deficiency called IgA deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Mothers with Fetuses Who Have 2° AVB or AV interval > 170ms
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger