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 dise
| Condition(s) | Heart Block Complete, Heart Block Second Degree |
|---|---|
| Status | Recruiting |
| 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 |
| Who can participate | 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 h |
| Ages | 16 Years to 50 Years |
| Sex | Female |
| Lead sponsor | The Hospital for Sick Children |
| Locations | Phoenix, Arizona, United States; San Francisco, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; St. Petersburg, Florida, United States; Kansas City, Kansas, United States (+21 more sites) |
| Start date | 2020-01-01 |
| NCT ID | NCT04559425 |
| Official listing | https://clinicaltrials.gov/study/NCT04559425 |