Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738749
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:

Congestive heart failure (CHF) represents a major health care concern in the United States. Currently, risk stratification of sudden cardiac death and the need for implantable cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is suboptimal, alternative testing for risk assessment for the development of sudden cardiac death in the heart failure population is desirable.

At the genome level, the investigator has focused on the role of SCN5A gene mutations in arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk populations. This study will determine if SCN5A variant levels are predictive of appropriate ICD therapies in patients with a newly implanted ICD.


Condition or disease Intervention/treatment Phase
Death, Sudden, Cardiac Device: Implantable cardioverter-defibrillator (ICD) Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Sodium Channel Splicing in Heart Failure Trial (SOCS-HEFT) Prospective Study
Study Start Date : June 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ICD group
Adult patients with newly implanted ICD devices for primary prevention will be enrolled. At baseline, 3-, 6-, 9-, and 12-month followup visit, the medial information and blood samples will be collected.
Device: Implantable cardioverter-defibrillator (ICD)
Patients with newly implanted implantable cardioverter-defibrillators (ICDs) for primary prevention will be enrolled.




Primary Outcome Measures :
  1. The levels of sodium channel splicing variants measured by gene expression that are related to arrhythmic events, change every 3 months from baseline to one 1 year after ICD therapy. [ Time Frame: baseline, 3-month, 6-month, 9-month, and 12-month after ICD therapy ]

Secondary Outcome Measures :
  1. The levels of sodium channel splicing variants measured by gene expression that are related to the type of ICD implanted, change every 3 months from baseline to one 1 year after ICD therapy. [ Time Frame: baseline, 3-month, 6-month, 9-month, and 12-month after ICD therapy ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must be greater than 18 years of age.
  2. All patients must be able to give informed consent.
  3. Patients must receive an ICD within 10 days for primary prevention.

Exclusion Criteria:

  1. Patients less than 18 years of age.
  2. History of congenital heart disease.
  3. History of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease.
  4. Patients have an ICD implanted for secondary prevention.
  5. Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression.
  6. Patients with any illness expected to result in death within 18 months of enrollment.
  7. Patients with white blood cell dyscrasia or cancers.
  8. Patients with end-stage renal disease (ESRD) on hemodialysis or peritoneal dialysis
  9. Current illicit drug use.
  10. Inability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738749


Contacts
Layout table for location contacts
Contact: Lori-Ann DeSimone, RN,BSN (401) 793-5554
Contact: Michael Orlov, MD 401-793-4107

Locations
Layout table for location information
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Lori-Ann Desimone, RN, BSN    401-793-5554      
Contact: Michael Orlov, MD    401-793-4107      
Principal Investigator: Michael Orlov, MD         
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Layout table for investigator information
Principal Investigator: Michael Orlov, MD Rhode Island Hospital

Publications:
Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. Epub 2005 Sep 13.

Layout table for additonal information
Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02738749     History of Changes
Other Study ID Numbers: 426228-16
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhode Island Hospital:
sudden cardiac death, sodium channel splicing variant
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Death, Sudden, Cardiac
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Death
Pathologic Processes
Heart Arrest