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

Recruitingn/aAges 16 Years - 50 YearsFemaleThe Hospital for Sick Children
NCT04559425 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Dexamethasone
  • No Dexamethasone
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Where

27 sites
Phoenix Children's Hospital
Phoenix, United States
University of California San Francisco
San Francisco, United States
Children's Hospital Colorado
Denver, United States
Children's National Medical Center
Washington D.C., United States
Johns Hopkins All Children's Hospital
St. Petersburg, United States
Children's Mercy Kansas City
Kansas City, United States
Boston Children's Hospital
Boston, United States
The Children's Heart Clinic/Children's Minnesota
Minneapolis, United States

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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