An observational study in Heart Block Complete and Heart Block Second Degree, sponsored by The Hospital for Sick Children. Recruiting at 27 sites in 12 countries. Open to female participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-05-22.
Sponsored by The Hospital for Sick Children · Observational
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.
The SLOW HEART REGISTRY is a multi-centered prospective observational study of fetuses diagnosed with high-degree immune-mediated atrio-ventricular heart block (AVB). 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.
The study aims are to document the outcome of patients diagnosed prenatally with immune-mediated 2nd or 3rd degree AVB irrespective of the primary choice of prenatal care.
The primary objective will be to determine the rate of transplant-free survival to 1 year of life of fetuses with AVB based on the prenatal management decision:
Secondary objectives will be to determine:
Prevalence of relevant fetal-maternal events and complications (death; IUGR; morbidity) between the study cohorts will also be determined.
All management is decided by the treating center and physicians in accordance to institutional guidelines and clinical findings. Patient enrollment in the SLOW HEART REGISTRY is possible within up to 8 days of the initial management decision.
Participation in this prospective observational cohort study requires site REB approval and an executed legal contract with the primary investigator/SickKids Hospital, Toronto.
72 studies on the registry are indexed under Heart Block; 18 are open to participants now.
This study's planned enrollment of 350 is close to the median of 380 across 30 observational studies indexed under Heart Block.
Browse Heart Block studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Enrollment into the SLOW HEART Registry is possible within maximally 8 days of the fetal heart block diagnosis and a management decision to treat or not to treat. If a mother elects participation in the Registry, her treating physician will continue to provide care in accordance with clinical practice at the site and will decide all therapy including close observation without or with immediate steroid treatment.
Exclusion Criteria:
Complete AVB (3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
Drug: Dexamethasone · Other: No Dexamethasone
Incomplete AVB (2nd; 2:1; 2nd-3rd degree) diagnosed ≤ 32+0 weeks with or without hydrops
Drug: Dexamethasone · 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
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
Freedom from cardiac death ≥1 year of life
Time frame: up to 12 months
Proportion of participants with fetal and neonatal death and their causes/factors
Time frame: 1 month
Proportion of participants with change in prenatal treatment
Time frame: up to 6 months
Proportion of secondarily treated patients (initially untreated group 1 cases)
Time frame: up to 6 months
Proportion of serious pregnancy outcomes (IUFD, IUGR <3rd percentile, delivery <35 weeks)
Time frame: up to 6 months
Proportion of patients/group with progression from incomplete to complete AVB by 1 year
Time frame: Fetal diagnosis to 12 months
Proportion of maternal serious adverse events and outcomes
Time frame: Fetal diagnosis to 12 months
Average gestational age at birth
Time frame: Birth
Average birth weight
Time frame: Birth
Freedom from permanent pacemaker implantation from birth to 1 year of life
Time frame: Birth to 12 months
Prevalence of significant heart failure (HF score, echo, HF treatment) at 1 year of life
Time frame: 12 months
Proportion of children with moderate/severe neuro-developmental delay at 12-18 months
Time frame: 12-18 months
Plan to share: No
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