Status:
COMPLETED
Sodium Channel Splicing in Heart Failure Trial
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
Jesse Brown VA Medical Center
Conditions:
Atrial Fibrillation
Atrial Flutter
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this research is to see if investigators can detect truncated mRNA splice variants of the cardiac voltage-gated sodium (Na+) channel gene, SCN5A, in patients with a weak heart (Heart Fa...
Detailed Description
Scientific Background and Significance Introduction: Congestive heart failure (CHF) represents a major health care concern in the United States. It has been estimated that approximately 5 million pa...
Eligibility Criteria
Inclusion
- All patients must be greater than 18 years of age
- Patients with reduced left ventricular function (i.e., heart failure patients) must have acquired heart failure and an ejection fraction less than 35% documented in the last two years by any methodology
- Control population patients must be free of heart failure symptoms, diastolic dysfunction, and left ventricular systolic dysfunction documented by any methodology within 1 year of study enrollment
- Patients with an ICD in place for more than 1 year and evidence of ICD events
- Patients with an ICD in place for more than 1 year and no evidence of ICD events
- All patients must be able to give informed consent
Exclusion
- Patients less than 18 years of age.
- History of congenital heart disease as cause of impaired left ventricular function.
- Control patients with impaired left ventricular systolic function or the presence of diastolic dysfunction.
- Control or Study group patients with a history of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease will not be included.
- Control or Study group patients who require antiarrhythmic drugs other than Vaughn-Williams Class II and IV agents.
- Control patients with a history of significant illness that may otherwise impair cardiac function within 12 months of study enrollment. These conditions include: myocardial infarction, cardiac hospitalization, cardiac arrhythmia, infection, or cancer.
- ICD patients suffering from any other terminal or chronic inflammatory illness.
- Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression.
- Patients with any illness expected to result in death within 18 months of enrollment.
- Patients with white blood cell dyscrasia or cancers.
- Current illicit drug use.
- Inability to give informed consent.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT01185587
Start Date
February 1 2010
End Date
April 1 2014
Last Update
April 23 2014
Active Locations (2)
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1
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612