Sodium Channel Splicing in Heart Failure Trial (SOCS-HEFT)

This study has been completed.
Sponsor:
Collaborator:
Jesse Brown VA Medical Center
Information provided by (Responsible Party):
Samuel C. Dudley, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01185587
First received: August 17, 2010
Last updated: April 21, 2014
Last verified: April 2014
  Purpose

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 Failure) with or without an implantable cardioverter-defibrillator (ICD) and compare them to patients with a normal heart.

Hypothesis:

  1. Patients with reduced left ventricular ejection fraction have increased abundances truncated mRNA splice variants of the SCN5A gene, which portends to sodium channel dysfunction and an increased risk for sudden cardiac death.
  2. Patients with implantable cardioverter-defibrillator devices (ICDs) who have experienced shock therapy have increased abundances of truncated mRNA splice variants of the SCN5A gene compared to similar congestive heart failure patients who have not experienced shock therapy.

Condition
Atrial Fibrillation
Atrial Flutter
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sodium Channel Splicing in Heart Failure Trial

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Amount of sodium channel splice variants [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    We will correlate the amount of white cell Na+ channel splice variants with ejection fraction in patients with an without heart failure and with the number of shocks in the patients with ICDs.


Secondary Outcome Measures:
  • ACE mRNA [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    upstream signals for abnormal SCN5A mRNA splicing

  • Ang II mRNA [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    upstream signals for abnormal SCN5A mRNA splicing

  • HIF-1α mRNA [ Time Frame: At enrollment ] [ Designated as safety issue: No ]
    upstream signals for abnormal SCN5A mRNA splicing


Biospecimen Retention:   Samples Without DNA

Whole blood


Enrollment: 147
Study Start Date: February 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy patients with a normal heart
patients with HF without an lCD
patients with HF and an ICD without shock
patients with HF and an ICD with shock

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Heart Failure and Device Clinics

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185587

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Jesse Brown VA Medical Center
Investigators
Principal Investigator: Samuel C. Dudley, Jr., MD, PhD University of Illinois at Chicago
  More Information

Publications:
Responsible Party: Samuel C. Dudley, Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01185587     History of Changes
Other Study ID Numbers: 2009-1187
Study First Received: August 17, 2010
Last Updated: April 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
SCN5A protein
voltage-gated Na+ channel

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014