Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 50
View:

• 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

Locations
United States
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
University of California San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital Colorado
RECRUITING
Denver
Washington, D.c.
Children's National Medical Center
RECRUITING
Washington D.c.
Florida
Johns Hopkins All Children's Hospital
RECRUITING
St. Petersburg
Kansas
Children's Mercy Kansas City
RECRUITING
Kansas City
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Minnesota
The Children's Heart Clinic/Children's Minnesota
RECRUITING
Minneapolis
New York
Columbia University (New York)
RECRUITING
New York
Texas
Texas Children's Hospital
RECRUITING
Houston
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Bulgaria
National Heart Hospital
RECRUITING
Sofia
Canada
IWK Nova Scotia Health
RECRUITING
Halifax
The Hospital for Sick Children
RECRUITING
Toronto
Finland
Hospital District of Helsinki and Uusimaa
RECRUITING
Helsinki
France
Grenoble University Hospital
RECRUITING
Grenoble
Germany
University of Bonn
RECRUITING
Bonn
Hong Kong Special Administrative Region
Hong Kong Children's Hospital
RECRUITING
Ngau Tau Kok
Japan
Kanagawa Children's Medical Center
RECRUITING
Kanagawa
Shizuoka Children's Hospital
RECRUITING
Shizuoka
Netherlands
Leiden University Medical Center - LUMC
RECRUITING
Leiden
Poland
Centre of Postgraduate Medical Education Poland
RECRUITING
Warsaw
Sweden
Queen Silvia Children's Hospital
RECRUITING
Gothenburg
Skane University Hospital in Lund
RECRUITING
Lund
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
RECRUITING
Solna
Taiwan
Taiji Clinic
RECRUITING
Taipei
Contact Information
Primary
Diana Balmer-Minnes, BSc, CCRP
slow.heart@sickkids.ca
416-813-7654
Backup
Edgar Jaeggi, MD
slow.heart@sickkids.ca
418-813-7466
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 350
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: The Hospital for Sick Children

This content was sourced from clinicaltrials.gov