Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
1 other identifier
observational
350
12 countries
27
Brief Summary
Few studies are specifically designed to address health concerns that are already relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally slow heart rate due to maternal antibody-mediated heart disease in the unborn baby (fetus). Since the late seventies, it has been possible to detect and monitor fetal disease by ultrasound images and to treat selected conditions with pharmaceuticals administered via the mother. To this day, physicians need to make decisions about the management of such pregnancies without evidence from prospective clinical trials on drug efficacy and safety. The SLOW HEART REGISTRY is a multi-centered prospective observational study that will address the knowledge gap to guide future management of high-degree immune-mediated heart block to the best of care. The study seeks to establish an international database of the management and outcome of affected fetuses, to be used to publish information on the results of currently available prenatal care and to evaluate the need for additional research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
September 11, 2020
CompletedFirst Posted
Study publicly available on registry
September 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
May 22, 2024
May 1, 2024
8 years
September 11, 2020
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Freedom from cardiac death ≥1 year of life
up to 12 months
Secondary Outcomes (11)
Proportion of participants with fetal and neonatal death and their causes/factors
1 month
Proportion of participants with change in prenatal treatment
up to 6 months
Proportion of secondarily treated patients (initially untreated group 1 cases)
up to 6 months
Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks)
up to 6 months
Proportion of patients/group with progression from incomplete to complete AVB by 1 year
Fetal diagnosis to 12 months
- +6 more secondary outcomes
Study Arms (2)
Prospective observational cohort 1
Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
Prospective observational cohort 2
Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
Interventions
All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment
All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment
Eligibility Criteria
Enrollment into the SLOW HEART Registry is possible within maximally 8 days of the fetal heart block diagnosis and a management decision to treat or not to treat. If a mother elects participation in the Registry, her treating physician will continue to provide care in accordance with clinical practice at the site and will decide all therapy including close observation without or with immediate steroid treatment.
You may qualify if:
- 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
You may not qualify if:
- 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
- st 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of California San Francisco
San Francisco, California, 94143, United States
Children's Hospital Colorado
Denver, Colorado, 80205, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Mercy Kansas City
Kansas City, Kansas, 64108, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
The Children's Heart Clinic/Children's Minnesota
Minneapolis, Minnesota, 55404, United States
Columbia University (New York)
New York, New York, 10027, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
National Heart Hospital
Sofia, Bulgaria
IWK Nova Scotia Health
Halifax, Nova Scotia, B3K 6R8, Canada
The Hospital for Sick Children
Toronto, Canada
Hospital District of Helsinki and Uusimaa
Helsinki, 00260, Finland
Grenoble University Hospital
Grenoble, France
University of Bonn
Bonn, Germany
Hong Kong Children's Hospital
Ngau Tau Kok, Hong Kong
Kanagawa Children's Medical Center
Kanagawa, Japan
Shizuoka Children's Hospital
Shizuoka, Japan
Leiden University Medical Center - LUMC
Leiden, Netherlands
Centre of Postgraduate Medical Education Poland
Warsaw, Poland
Queen Silvia Children's Hospital
Gothenburg, Sweden
Skane University Hospital in Lund
Lund, Sweden
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
Solna, Sweden
Taiji Clinic
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edgar Jaeggi, MD
The Hospital for Sick Children, Toronto
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Associate Scientist Emeritus
Study Record Dates
First Submitted
September 11, 2020
First Posted
September 22, 2020
Study Start
January 1, 2020
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
May 22, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share