Congestive heart failure (CHF) is a common and lethal disease. A new diagnosis of CHF is made in 400,000 Americans each year. Those with moderate left ventricular dysfunction have a death rate of 25% over 2 1/2 years, with 50% thought to be due to arrhythmias. The central hypothesis of this study is that amiodarone or an implantable cardioverter-defibrillator (ICD) will improve survival compared to placebo in patients with NYHA Class II and Class III CHF and reduced left ventricular ejection fraction, less than or equal to 35%. The study will be a prospective, clinical trial with 2,500 patients randomly allocated in equal proportions to three different treatment arms over 2 1/2 years. The first arm of the study will consist of conventional heart failure therapy and placebo. The second arm of the study will combine conventional therapy with amiodarone. The third arm of the study will employ conventional therapy with a pectoral ICD. Treatment arms will be compared using an intention-to-treat analysis. We have one primary specific aim: 1. To compare all cause mortality-based on a minimum of 2 1/2 years of follow-up in the three arms of the study. We have five secondary specific aims: 1. To determine the incidence of cardiac mortality and arrhythmic mortality, 2. To determine the incidence of VT/VF and profound bradyarrhythmias (rates less than or equal to 30 bpm) in CHF patients in the ICD arm via the ICD memory log, 3. To compare morbidity in each of the three arms of the study, 4. To compare health-related quality of life in the three arms of the study, 5. To compare cost of care for each treatment group and calculate incremental cost-effectiveness ratios for the two intervention arms. The study will be performed at 95 North American Institutions. The Clinical Coordinating Center is the University of Washington in Seattle while the Data Coordinating Center and the Economics and Quality of Life Coordinating centers are at Duke University. The ICD Memory Log Core Laboratory is a subunit of the Clinical Coordinating Center focusing on secondary specific aim #2.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL055766-05
Application #
6389551
Study Section
Special Emphasis Panel (ZHL1-CCT-H (M1))
Program Officer
Boineau, Robin
Project Start
1997-05-01
Project End
2003-04-30
Budget Start
2001-05-01
Budget End
2002-04-30
Support Year
5
Fiscal Year
2001
Total Cost
$669,974
Indirect Cost
Name
Seattle Institute for Cardiac Research
Department
Type
DUNS #
012799156
City
Bellevue
State
WA
Country
United States
Zip Code
98116
Patton, Kristen K; Hellkamp, Anne S; Lee, Kerry L et al. (2014) Unexpected deviation in circadian variation of ventricular arrhythmias: the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial). J Am Coll Cardiol 63:2702-8
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
Kao, Chi-Wen; Friedmann, Erika; Thomas, Sue A (2010) Quality of life predicts one-year survival in patients with implantable cardioverter defibrillators. Qual Life Res 19:307-15
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

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