Sodium Channel Splicing in Heart Failure Trial (SOCS-HEFT) Prospective Study
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|ClinicalTrials.gov Identifier: NCT02738749|
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 12, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
- 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 ]
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
|Contact: Lori-Ann DeSimone, RN,BSN||(401) 793-5554|
|Contact: Michael Orlov, MD||401-793-4107|
|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|
|Principal Investigator:||Michael Orlov, MD||Rhode Island Hospital|