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Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
Sponsor study identifier
observational
350
12 countries
27
Study Start
January 1, 2020
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2020
Actual (reported)September 11, 2020
Actual (reported)September 22, 2020
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Freedom from cardiac death ≥1 year of life
up to 12 months
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
Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
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
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.
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
University of California San Francisco
San Francisco, California, 94143, United States
Edgar Jaeggi, MD
The Hospital for Sick Children, Toronto
First Submitted
September 11, 2020
First Posted
September 22, 2020
Study Start
January 1, 2020
Actual (reported)Primary Completion
December 31, 2027
EstimatedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 22, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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