Sodium Channel Splicing in Heart Failure Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01185587
• Date of registration: 17/08/2010
• Primary sponsor: University of Illinois
• Public title: Sodium Channel Splicing in Heart Failure Trial SOCS-HEFT
• Scientific title: Sodium Channel Splicing in Heart Failure Trial
• Date of first enrolment: February 2010
• Target sample size: 180
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01185587
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Retrospective

Countries of recruitment

United States

Contacts

• Name: Mihai Raicu, MS

• Name: Samuel C. Dudley, Jr., MD, PhD
• Affiliation: University of Illinois

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Atrial Flutter

Heart Failure

Primary Outcome(s)

Amount of sodium channel splice variants [Time Frame: At enrollment]

Secondary Outcome(s)

ACE mRNA [Time Frame: At enrollment]

Ang II mRNA [Time Frame: At enrollment]

HIF-1a mRNA [Time Frame: At enrollment]

Secondary ID(s)

2009-1187

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jesse Brown VA Medical Center