Registry for Fetal Immune-mediated Heart Block
Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
This study is trying to see how different treatments for fetuses with a serious heart condition affect their health and survival as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 27 sites (Phoenix, Arizona and 26 other locations) |
| Trial ID | NCT04559425 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women whose fetuses have been diagnosed with high-degree AVB and have positive or pending anti-Ro/La antibody test results.
Not a fit: Patients whose AVB is associated with major congenital heart defects or who have negative anti-Ro/La antibody test results may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve prenatal management strategies for fetuses with immune-mediated heart block, potentially enhancing survival rates and health outcomes.
How similar studies have performed: While there is limited evidence from similar studies, this registry approach is novel and aims to fill a critical knowledge gap in the management of fetal heart block.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 26 other locations
- 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)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- The Children's Heart Clinic/Children's Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Columbia University (New York) — New York, New York, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- National Heart Hospital — Sofia, Bulgaria (Recruiting)
- IWK Nova Scotia Health — Halifax, Nova Scotia, Canada (Recruiting)
- The Hospital for Sick Children — Toronto, Canada (Recruiting)
- Hospital District of Helsinki and Uusimaa — Helsinki, Finland (Recruiting)
- Grenoble University Hospital — Grenoble, France (Recruiting)
- University of Bonn — Bonn, Germany (Recruiting)
- Hong Kong Children's Hospital — Ngau Tau Kok, Hong Kong (Recruiting)
- Kanagawa Children's Medical Center — Kanagawa, Japan (Recruiting)
- Shizuoka Children's Hospital — Shizuoka, Japan (Recruiting)
- Leiden University Medical Center - LUMC — Leiden, Netherlands (Recruiting)
- Centre of Postgraduate Medical Education Poland — Warsaw, Poland (Recruiting)
- Queen Silvia Children's Hospital — Gothenburg, Sweden (Recruiting)
- Skane University Hospital in Lund — Lund, Sweden (Recruiting)
- Karolinska University Hospital, Astrid Lindgen Childrens Hospital — Solna, Sweden (Recruiting)
- Taiji Clinic — Taipei, Taiwan (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.