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Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
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
🗓️ Study Start (Actual) 1 January 2020
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 December 2029
👥 Enrollment (Estimated) 350
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Phoenix, Arizona, United States
📍 San Francisco, California, United States
📍 Denver, Colorado, United States
📍 Washington, District of Columbia, United States
📍 Saint Petersburg, Florida, United States
📍 Kansas City, Kansas, United States
📍 Boston, Massachusetts, United States
📍 Minneapolis, Minnesota, United States
📍 New York, New York, United States
📍 Houston, Texas, United States
📍 Seattle, Washington, United States
📍 Milwaukee, Wisconsin, United States
📍 Sofia, Bulgaria
📍 Halifax, Nova Scotia, Canada
📍 Toronto, Canada
📍 Helsinki, Finland
📍 Grenoble, France
📍 Bonn, Germany
📍 Ngau Tau Kok, Hong Kong
📍 Kanagawa, Japan
📍 Shizuoka, Japan
📍 Leiden, Netherlands
📍 Warsaw, Poland
📍 Gothenburg, Sweden
📍 Lund, Sweden
📍 Solna, Sweden
📍 Taipei, Taiwan
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * AVB associated with major CHD (e.g. left atrial isomerism, cc-TGA)
    • * AVB with known negative anti-Ro and/or La antibody test result at enrollment
    • * 1st degree AVB
    • * Sinus bradycardia with normal 1:1 AV conduction
    • * Blocked atrial bigeminy (irregular atrial rate with failure of AV conduction of the premature atrial beat)
    • * Primary delivery for postnatal treatment
    • * 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.)
    • * Preexisting maternal mental disorder (e.g. bipolar, mania, severe depression, substance abuse)
    • * Poorly controlled insulin-dependent diabetes (HbA1c \>7%) at CAVB diagnosis
    • * Oligohydramnios (deepest/maximal vertical pocket \<2 cm)
    • * Severe IUGR (estimated fetal weight \<3rd percentile)
Ages Eligible for Study: 16 Years to 50 Years (CHILD, ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 11 September 2020
  • First Submitted that Met QC Criteria 21 September 2020
  • First Posted 22 September 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 May 2024
  • Last Update Posted 22 May 2024
  • Last Verified May 2024
I'm interested ...!!