What side effects are associated with this type of intervention?

The most common treatments for atrioventricular block (AVB) include sympathomimetic drugs and dexamethasone. Sympathomimetic drugs, while effective, are often poorly tolerated by mothers due to side effects such as increased heart rate, anxiety, and hypertension. Dexamethasone, although it does not directly affect AV block or heart rate, may improve clinical tolerance of conduction disturbances but can have side effects like immunosuppression, increased blood sugar levels, and potential impacts on fetal growth.

What prior FDA approvals exist?

FDA-approved treatments for Atrioventricular Block (AVB) primarily include pacemaker implantation, which is standard for managing advanced AVB in both adults and children. In fetal cases, treatments are more experimental, such as maternal administration of medications like ritodrine to manage fetal heart rate and prevent progression to complete AVB. These approaches aim to detect and intervene early in conditions like 2° AVB, similar to the strategies being studied in the Fetal Heart Rate and Rhythm Monitoring (FHRM) trial.

What other types of research exist?

Promising novel alternatives to Fetal Heart Rate and Rhythm Monitoring (FHRM) for early detection and intervention of 2° AVB in 2024 include: 1) Advanced wearable technology with continuous monitoring capabilities, 2) Telemedicine platforms for real-time data sharing and remote consultations, 3) Genetic screening and biomarker analysis for early risk assessment, and 4) AI and ML algorithms for predictive analytics and early diagnosis.

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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

No Placebo-Only Group

Pivotal Trial

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 below

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I live within a 6-hour drive of the pediatric cardiology site.

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I am less than 18 weeks pregnant.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking more than 20 mg of prednisone or any dose of fluorinated steroids currently.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-birth for reporting.

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 • NCT03065244

17%

Continued Fever after treatment completion and crossover to other study treatment

15%

Fever following crossover treatment

15%

Fever after discharge not attributed to KD

GI Symptoms

Rash

Arthritis/pain and swelling in extremities

Epistaxis

Leukemoid Reaction

Hemolytic Anemia

Hyperhidrosis

Dress Syndrome

Pancreatitis

URI

Chest Pain

Color Blindness

Headache

Pain (IV Site)

100%

80%

60%

40%

20%

Study treatment Arm

Infliximab

IVIG

Awards & Highlights

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.

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

0 / 5Eligibility criteria met

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.