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Slow Heart Registry for Fetal Immune-mediated High Degree Heart Block

This study is creating a registry to learn more about how to best care for unborn babies (fetuses) who have a very slow heartbeat, called high-degree heart block. This condition is caused by the mother's immune system. Doctors currently make treatment decisions without clear evidence from studies. This registry will collect information on how these pregnancies are managed and what happens to the babies. The study is looking at two groups: those whose mothers receive Dexamethasone (a medication) and those who do not. The main goal is to see how many babies survive for at least one year without needing a heart transplant. You may be able to join if you are a woman between 16 and 50 years old, have a fetus diagnosed with high-degree heart block before 32 weeks of pregnancy, and have certain antibodies (anti-Ro/La).

Study design
This is an observational study, meaning researchers will collect information without giving specific treatments. It aims to enroll 350 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year after the baby's birth to assess survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04559425

Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

Recruiting
Not specifiedAges 16–50Observational
The Hospital for Sick Children
~350 participants
Updated 2024-05-22 on ClinicalTrials.gov
What's tested:DexamethasoneNo Dexamethasone

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from cardiac death ≥1 year of life
Measured over up to 12 months

Conditions

Heart Block Complete
Heart Block Second Degree

Explore related trials

Heart blockanti-RoBlood group antibody A>1<

Where it's being run

27 sites across 24 states
Sweden3
Japan2
Arizona1
California1
Colorado1
District of Columbia1
Florida1
Kansas1

Study leadership

  • Edgar Jaeggi, MD · PRINCIPAL_INVESTIGATOR · The Hospital for Sick Children, Toronto

Who to contact

Diana Balmer-Minnes, BSc, CCRP
[email protected]
416-813-7654 · ext. 228624
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Written informed maternal consent to participate in the Slow Heart Registry
High-degree (2nd; 2:1; 2nd-3rd or 3rd degree) AVB diagnosed ≤ 32+0 weeks with or without hydrops
Enrollment within maximally 8 days of high-degree AVB diagnosis
Positive or pending anti-Ro/La antibody test results at the time of enrollment

Exclusion

AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)
AVB with known negative anti-Ro and/or La antibody test result at enrollment
1st degree AVB
Sinus bradycardia with normal 1:1 AV conduction
Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)
Primary delivery for postnatal treatment
Maternal-fetal conditions (other than cardiac NL) associated with high odds of premature delivery or death (e.g. renal failure, significant infectious diseases, major extracardiac anomalies, PROM, etc.)
Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)
Poorly controlled insulin-dependent diabetes (HbA1c \>7%) at CAVB diagnosis
Oligohydramnios (deepest/maximal vertical pocket \<2 cm)
Severe IUGR (estimated fetal weight \<3rd percentile)

What this trial measures

  • Freedom from cardiac death ≥1 year of lifeup to 12 months