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Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block

NCT04559425 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2024-05-22

No results posted yet for this study

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.

Conditions

  • Heart Block Complete
  • Heart Block Second Degree

Interventions

DRUG

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

OTHER

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

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Edgar Jaeggi, MD · The Hospital for Sick Children, Toronto

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Finland
  • France
  • Germany
  • Hong Kong
  • Japan
  • Netherlands
  • Poland
  • Sweden
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559425 on ClinicalTrials.gov