The objective of this proposal is to perform one additional year of follow-up data collection in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) in order to accrue the number of events required to preserve the power of the study. SCD-HeFT is a multicenter randomized clinical trial of prophylactic amiodarone or implantable defibrillator therapy versus conventional heart failure medical therapy in patients with Class II or Class III heart failure, an ejection fraction equal to or <0.35, and no previous sustained ventricular arrhythmias. NHLBI funding for the trial was awarded for a six-year period beginning May 1, 1997 and ending April 30, 2003. Patient enrollment in the trial began September 16, 1997, and was completed July 18, 2001, upon reaching the target enrollment of 2,500 patients (final enrollment is 2,521). Patient follow-up is on-going, and under present funding timelines, will have to be terminated by October 31, 2002 to allow time for closing out the trial, completing the study database, analyzing the data, and preparing the main trial reports before funding expires. In the original study plan, the six-year timeline for the trial included 2.5 years of patient recruitment and 2.5 years of subsequent follow-up. Despite a three-fold increase in the number of clinical sites, and numerous creative recruitment strategies, patient enrollment required nearly four years. If the original timeline for closing the study is maintained, the average length of follow-up will fall short of the originally planned average follow-up by at least one full year. The key concern is that the number of events required to achieve an appropriate level of statistical power will not have occurred. An additional year of follow-up will allow the study to accrue the number of events that are consistent with the original design of the trial, improve the precision for assessing the true effects of these interventions, and thereby provide the clinical and scientific community with therapeutic information urgently needed for the rapidly growing population of heart failure patients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01HL055297-07
Application #
6560540
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Boineau, Robin
Project Start
1997-05-01
Project End
2005-04-30
Budget Start
2003-06-16
Budget End
2005-04-30
Support Year
7
Fiscal Year
2003
Total Cost
$1,229,006
Indirect Cost
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Au-Yeung, Wan-Tai M; Reinhall, Per G; Poole, Jeanne E et al. (2015) SCD-HeFT: Use of R-R interval statistics for long-term risk stratification for arrhythmic sudden cardiac death. Heart Rhythm 12:2058-66
Fishbein, Daniel P; Hellkamp, Anne S; Mark, Daniel B et al. (2014) Use of the 6-min walk distance to identify variations in treatment benefits from implantable cardioverter-defibrillator and amiodarone: results from the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol 63:2560-2568
Friedmann, Erika; Son, Heesook; Thomas, Sue A et al. (2014) Poor social support is associated with increases in depression but not anxiety over 2 years in heart failure outpatients. J Cardiovasc Nurs 29:20-8
Aoukar, Pierre S; Poole, Jeanne E; Johnson, George W et al. (2013) No benefit of a dual coil over a single coil ICD lead: evidence from the Sudden Cardiac Death in Heart Failure Trial. Heart Rhythm 10:970-6
Mitchell, Judith E; Hellkamp, Anne S; Mark, Daniel B et al. (2013) Thyroid function in heart failure and impact on mortality. JACC Heart Fail 1:48-55
Chen, Jay; Johnson, George; Hellkamp, Anne S et al. (2013) Rapid-rate nonsustained ventricular tachycardia found on implantable cardioverter-defibrillator interrogation: relationship to outcomes in the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol 61:2161-8
Piccini, Jonathan P; Al-Khatib, Sana M; Hellkamp, Anne S et al. (2011) Mortality benefits from implantable cardioverter-defibrillator therapy are not restricted to patients with remote myocardial infarction: an analysis from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). Heart Rhythm 8:393-400
Strauss, David G; Poole, Jeanne E; Wagner, Galen S et al. (2011) An ECG index of myocardial scar enhances prediction of defibrillator shocks: an analysis of the Sudden Cardiac Death in Heart Failure Trial. Heart Rhythm 8:38-45
Packer, Douglas L; Prutkin, Jordan M; Hellkamp, Anne S et al. (2009) Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial. Circulation 120:2170-6
Thomas, Sue A; Friedmann, Erika; Gottlieb, Stephen S et al. (2009) Changes in psychosocial distress in outpatients with heart failure with implantable cardioverter defibrillators. Heart Lung 38:109-20

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