Viewing Study NCT02045043



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Study NCT ID: NCT02045043
Status: COMPLETED
Last Update Posted: 2014-01-24
First Post: 2014-01-22

Brief Title: Genetic Risk Assessment of Defibrillator Events
Sponsor: University of Iowa
Organization: University of Iowa

Study Overview

Official Title: Genetic Risk Assessment of Defibrillator Events A Prospective Multicenter Observational Study
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: GRADE
Brief Summary: Arrhythmias remain a major health problem causing at least 250000 deaths annually in the United States Pharmacological treatments often do more harm than good and device therapies are limited by high cost and effects on quality of life Ion channel mutations cause rare inherited arrhythmopathies but account for only a small fraction of patients with life- threatening arrhythmias and sudden death Most arrhythmias occur during myocardial ischemia following myocardial infarction and in patients with poor left ventricular LV function of any etiology Aside from ejection fraction EF few clinically useful indicators to stratify the risk of sudden death have been identified The role of subtle difference in ion channel expression andor structure in predisposing patients to arrhythmias and modulating the risk of sudden death is unknown

In this study we are prospectively testing whether polymorphisms in ion channels and ion channel modifying genes are associated with arrhythmias in a population with internal cardioverter-defibrillators ICDs and poor LV function We will test the hypothesis that functional polymorphisms in the coding sequences and promoter regions of cardiac genes eg ion channels beta-adrenergic receptors predispose individuals to arrhythmias and or heart failure progression

We hope to identify genetic predictors for the common forms of sudden cardiac death This would allow the identification of a subpopulation of heart failure patients that would benefit most from ICD placement
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01HL077398 NIH None httpsreporternihgovquickSearchR01HL077398