Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04559425 · ClinicalTrials.gov registry record
Slow Heart Registry of Fetal Immune-mediated High Degree Heart Block
A clinical trial of Heart Block Complete and Heart Block Second Degree, sponsored by The Hospital for Sick Children.
- Recruiting
- Registry status
- 350
- Enrollment target
- 20
- Study locations
NCT04559425: Recruiting study of Heart Block Complete and Heart Block Second Degree, sponsored by The Hospital for Sick Children.
NCT04559425 is a study of Heart Block Complete and Heart Block Second Degree that is actively recruiting participants, run by The Hospital for Sick Children. The registered enrollment target is 350 participants. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559425, a study of Heart Block Complete and Heart Block Second Degree, is actively recruiting participants, sponsored by The Hospital for Sick Children.
- RECRUITING
- Registry status
- 350 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT04559425 shows while recruiting
NCT04559425 is an observational study that tracks outcomes without assigning an intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap.
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.
NCT04559425 names 20 study sites across 14 states, led by Other, Arizona, California.
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.
What interventions are being tested in trial NCT04559425?
The interventions under investigation include: Dexamethasone (DRUG), No Dexamethasone (OTHER).
Who is sponsoring clinical trial NCT04559425?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00900575 · 350 participants · NA
Cervical Cancer Detection Using Optical Spectroscopy
- NCT01627821 · 350 participants · NA
Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
- NCT02357654 · 350 participants · Phase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
- NCT03997370 · 350 participants · Phase 1
Evaluation of Dosing Procedures of Chemotherapy Treatment (Carboplatin) With the Contrast Agent Iohexol
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI