Genetic Risk Assessment of Defibrillator Events

Completed

Conditions studied: Sudden Cardiac Death, Arrhythmias, Congestive Heart Failure, Cardiomyopathy

In brief

Arrhythmias remain a major health problem, causing at least 250,000 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 and/or 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 (e.g. 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.

Key facts

Study ID

NCT02045043

Run by

University of Iowa

People needed

1807

Starts

2002-03-01

Expected to finish

2012-06-01

Last updated by the study team

2014-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• An ICD placed during the last 5 years, or a planned ICD within 1 month
• Age 18 or older
• Left Ventricular Ejection fraction < or = 30%
• Ability to give informed consent

You may not qualify if…

• Patient refuses or is unable to give consent
• A life expectancy <6 months from a non-cardiac life threatening disease
• Ongoing Class IV heart failure symptoms despite treatment
• History of cardiac transplant or left ventricular assist device

Where it is running

• Emory University — Atlanta, Georgia, United States
• Massuchetts General Hospital — Boston, Massachusetts, United States
• The Ohio State University — Columbus, Ohio, United States
• Mid Ohio Cardiology — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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