Registry for Fetal Immune-mediated Heart Block

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SLOW HEART REGISTRY is a multi-centered observational study focused on fetuses diagnosed with high-degree immune-mediated atrio-ventricular heart block (AVB). It aims to create an international database to document management strategies and outcomes for affected fetuses, comparing those treated with glucocorticoids to those who are not. The study will evaluate various clinical outcomes, including survival rates and the need for additional treatments, from diagnosis through the first few years of life. This research addresses a significant gap in prenatal care by providing evidence-based insights into the management of this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• Phoenix Children's Hospital
  Phoenix, Arizona, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Children's Hospital Colorado
  Denver, Colorado, United States Recruiting
• Children's National Medical Center
  Washington D.C., District of Columbia, United States Recruiting
• Johns Hopkins All Children's Hospital
  St. Petersburg, Florida, United States Recruiting
• Children's Mercy Kansas City
  Kansas City, Kansas, United States Recruiting

Study contacts

• Principal investigator: Edgar Jaeggi, MD — The Hospital for Sick Children, Toronto
• Study coordinator: Diana Balmer-Minnes, BSc, CCRP
• Email: slow.heart@sickkids.ca
• Phone: 416-813-7654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.