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This study examines the splicing of sodium channel genes in patients with heart failure. It included adults over 18 with heart failure and reduced left-heart function, along with healthy individuals for comparison. It was carried out as a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. All patients must be greater than 18 years of age 2. 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 3. 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 4. Patients with an ICD in place for more than 1 year and evidence of ICD events 5. Patients with an ICD in place for more than 1 year and no evidence of ICD events 6. All patients must be able to give informed consent Exclusion Criteria: 1. Patients less than 18 years of age. 2. History of congenital heart disease as cause of impaired left ventricular function. 3. Control patients with impaired left ventricular systolic function or the presence of diastolic dysfunction. 4. Control or Study group patients with a history of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease will not be included. 5. Control or Study group patients who require antiarrhythmic drugs other than Vaughn-Williams Class II and IV agents. 6. 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. 7. ICD patients suffering from any other terminal or chronic inflammatory illness. 8. Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression. 9. Patients with any illness expected to result in death within 18 months of enrollment. 10. Patients with white blood cell dyscrasia or cancers. 11. Current illicit drug use. 12. Inability to give informed consent.