Clinical Research Directory
Browse clinical research sites, groups, and studies.
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
Sponsor: The Hospital for Sick Children
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.
Official title: Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block
Key Details
Gender
FEMALE
Age Range
16 Years - 50 Years
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2020-01-01
Completion Date
2029-12-31
Last Updated
2024-05-22
Healthy Volunteers
Not specified
Interventions
Dexamethasone
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
No Dexamethasone
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
Locations (27)
Phoenix Children's Hospital
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Children's Mercy Kansas City
Kansas City, Kansas, United States
Boston Children's Hospital
Boston, Massachusetts, United States
The Children's Heart Clinic/Children's Minnesota
Minneapolis, Minnesota, United States
Columbia University (New York)
New York, New York, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
National Heart Hospital
Sofia, Bulgaria
IWK Nova Scotia Health
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Canada
Hospital District of Helsinki and Uusimaa
Helsinki, 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