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Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
NCT04559425 · View on ClinicalTrials.gov ↗
Study 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 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 Studied
Interventions
- DRUG Dexamethasone
- OTHER No Dexamethasone
Study Locations (20)
Other
- National Heart Hospital — Sofia
- The Hospital for Sick Children — Toronto
- Hospital District of Helsinki and Uusimaa — Helsinki
- Grenoble University Hospital — Grenoble
- University of Bonn — Bonn
- Hong Kong Children's Hospital — Ngau Tau Kok
- Kanagawa Children's Medical Center — Kanagawa
Arizona
- Phoenix Children's Hospital — Phoenix
California
- University of California San Francisco — San Francisco
Colorado
- Children's Hospital Colorado — Denver
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Johns Hopkins All Children's Hospital — St. Petersburg
Kansas
- Children's Mercy Kansas City — Kansas City
Massachusetts
- Boston Children's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2029-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04559425
The ClinicalTrials.gov registry entry for NCT04559425 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hospital for Sick Children, which has 15 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Heart Block Complete appearing as the primary indexed condition, and to 2 interventions — of which Dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04559425 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04559425 about?
NCT04559425 is a clinical study titled "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...
What is the current status of trial NCT04559425?
This trial is currently recruiting. The enrollment target is 350 participants. The study started on 2020-01-01. Estimated completion is 2029-12-31.
What conditions does trial NCT04559425 study?
This clinical trial studies the following conditions: Heart Block Complete, Heart Block Second Degree. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04559425?
The interventions under investigation include: Dexamethasone (DRUG), No Dexamethasone (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04559425?
This trial is sponsored by The Hospital for Sick Children, which has 15 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04559425 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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