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NCT02876380 · ClinicalTrials.gov registry record
Prospective Identification of Long QT Syndrome in Fetal Life
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 25
- Enrollment target
NCT02876380: Completed study, sponsored by University of Colorado, Denver.
NCT02876380 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02876380 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG), strengthened by a positive family history and/or characteristic arrhythmias and confirmed by genetic testing. However, for several reasons such LQTS testing cannot be performed successfully before birth. First, fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited to fewer than 10 sites world-wide. Second, while genetic testing can be performed in utero, there is risk to the pregnancy and the fetus. Third, although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in \<25% of fetal LQTS cases. Rather, the most common presentation of fetal LQTS is sinus bradycardia, a subtle rhythm disturbance that often is unappreciated to be abnormal. Consequently, the majority of LQTS cases are unsuspected and undiagnosed during fetal life, with dire consequences. For example, maternal medications commonly used during pregnancy can prolong the fetal QT interval and may provoke lethal fetal ventricular arrhythmias. But the most significant consequence is the missed opportunity for primary prevention of life threatening ventricular arrhythmias after birth because the infant is not suspected to have LQTS before birth. The over-arching goal of the study is to overcome the barriers to prenatal detection of LQTS. The investigators plan to do so by developing an algorithm using fetal heart rate (FHR) which will discriminate fetuses with or without LQTS. Immediate Goal: The investigators propose a multicenter pre-birth observational cohort study to develop a Fetal Heart Rate (FHR)/Gestational Age (GA) algorithm from a cohort of fetuses recruited from 13 national and international centers where one parent is known by prior genetic testing to have a mutation in one of the common LQTS genes: potassium voltage-g
Primary Outcome
The investigators hypothesize that from this fetal cohort, they can construct a FHR/GA algorithm that will discriminate fetuses who inherit the parental LQTS mutation from those who do not, with an area under the ROC ≥0.75.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-11 |
| Est. Completion | 2019-07-08 |
What the finished NCT02876380 record still lists
NCT02876380 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02876380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02876380 about?
NCT02876380 is a clinical study titled "Prospective Identification of Long QT Syndrome in Fetal Life". The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG), strengthened by a positive family history and/or characteristic arrhythmias and confirmed by genetic testing. However, for several reasons such LQTS testing cannot be perfor...
What is the current status of trial NCT02876380?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2014-11. Estimated completion is 2019-07-08.
Who is sponsoring clinical trial NCT02876380?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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