SCD-HeFT 10 Year Follow-up (SCD-HeFT10 Yr)
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|ClinicalTrials.gov Identifier: NCT01058837|
Recruitment Status : Unknown
Verified February 2010 by Seattle Institute for Cardiac Research.
Recruitment status was: Active, not recruiting
First Posted : January 29, 2010
Last Update Posted : February 11, 2010
|Condition or disease|
|Left Ventricular Systolic Dysfunction Congestive Heart Failure Ischemic and Non-ischemic Cardiomyopathy Sudden Cardiac Death Primary Prevention|
Long-term outcome data for implantable cardioverter defibrillator (ICD) therapy is sorely needed. We will acquire these data by re-approaching the patient population from the original Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).[Bardy 2005] This research is supported by the National Heart Lung and Blood Institute of the National Institutes of Health.
SCD-HeFT was originally conducted from 1997 to 2003. It demonstrated unequivocally that ICD's save lives in patients with heart failure compared to placebo or amiodarone. More than 26 peer-reviewed publications, including three NEJM papers, have resulted from this work.[Bardy 2005, Poole 2008, Mark 2008] Despite the quality of SCD-HeFT and the evidence of the life-saving ability of ICD therapy, the role of ICD therapy in the management of patients with heart failure continues to be questioned. This study will provide long-term follow-up of the SCD-HeFT patients, which will now exceed 10 years on average.
|Study Type :||Observational|
|Estimated Enrollment :||1855 participants|
|Observational Model:||Case Control|
|Official Title:||Sudden Cardiac Death in Heart Failure Trial 10 Year Follow-up (SCD-HeFT 10 Year)|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||August 2011|
- To compare 10-year mortality data on the remaining 1855 SCD-HeFT patients since the close of follow-up from October 31, 2003 in the 3 arms of the trial (ICD, placebo and amiodarone)based upon an intent-to-treat and an on-treatment analysis. [ Time Frame: Two years ]
- To obtain outcome data in the major subgroups of SCD-HeFT: ischemic v. non-ischemic and NYHA Class II vs. Class III heart failure, and in woman and minorities. [ Time Frame: Two years ]
- To obtain 10-year ICD use rates (appropriate and inappropriate therapy), complication rates, lead failure rates and replacement rates. [ Time Frame: Two Years ]
- To validate or refute the observation that amiodarone increases mortality in NYHA Class III patients. [ Time Frame: Two years ]
- To obtain 10-year hospitalization and major procedure data. [ Time Frame: Two years ]
- To obtain 10-year quality of life data. [ Time Frame: Two years ]
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): NCT01058837
|United States, Washington|
|Seattle Institute for Cardiac Research|
|Bellevue, Washington, United States, 98004-2206|
|Principal Investigator:||Gust H. Bardy, MD||Seattle Institute for Cardiac Research|