RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-01-01
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04559425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed maternal consent to participate in the Slow Heart Registry
  2. * High-degree (2nd; 2:1; 2nd-3rd or 3rd degree) AVB diagnosed ≤ 32+0 weeks with or without hydrops
  3. * Enrollment within maximally 8 days of high-degree AVB diagnosis
  4. * Positive or pending anti-Ro/La antibody test results at the time of enrollment
  1. * AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)
  2. * AVB with known negative anti-Ro and/or La antibody test result at enrollment
  3. * 1st degree AVB
  4. * Sinus bradycardia with normal 1:1 AV conduction
  5. * Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)
  6. * Primary delivery for postnatal treatment
  7. * 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.)
  8. * Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)
  9. * Poorly controlled insulin-dependent diabetes (HbA1c \>7%) at CAVB diagnosis
  10. * Oligohydramnios (deepest/maximal vertical pocket \<2 cm)
  11. * Severe IUGR (estimated fetal weight \<3rd percentile)

Contacts and Locations

Study Contact

Diana Balmer-Minnes, BSc, CCRP
CONTACT
416-813-7654
slow.heart@sickkids.ca
Edgar Jaeggi, MD
CONTACT
418-813-7466
slow.heart@sickkids.ca

Principal Investigator

Edgar Jaeggi, MD
PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto

Study Locations (Sites)

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, District of Columbia, 20010
United States
Johns Hopkins All Children's Hospital
Saint 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

Collaborators and Investigators

Sponsor: The Hospital for Sick Children

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • fetal
  • heart block
  • anti-Ro antibodies
  • steroids
  • outcome

Additional Relevant MeSH Terms

  • Heart Block Complete
  • Heart Block Second Degree