The objective of this proposal is to establish an Economics and Quality of life Coordinating Center for SCD-HeFT, a multi-center clinical trial of prophylactic amiodarone or implantable defibrillator therapy versus conventional heart failure therapy in 2500 patients with Class II or Class III congestive heart failure (CHF) and an ejection fraction less than or equal to 35%.. All patients will receive conventional CHF therapy. Qualifying patients will be randomized in equal proportions to either amiodarone placebo, active amiodarone therapy, or a single lead, pectoral ICD that can be inserted on an outpatient basis. Patients will be recruited into the trial over a period of 2.5 years, with a subsequent minimum follow-up period of 2.5 years. The primary endpoint of the trial is all-caused mortality. Cost, cost effectiveness, and health-related quality of life are secondary endpoints. In collaboration with the Clinical Coordinating Center and the Statistical and Data Coordinating Center, the Economics and Quality of Life Coordinating Center will perform the Following major function: (1) obtain baseline economics status and quality of life data from all patients enrolled at each participating study site at the time of randomization; (2) collect detailed health care resource consumption data for the index medical encounter; (3) assess economic, functional status, and quality of life outcomes during follow-up clinic visits at 3 months, 1 year, and 2.5 years after enrollment; (4) identify all medical encounters that occur during follow-up and collect detailed health care resource consumption and cost data for each; (5) compare cost and quality of life outcomes for the three treatment arms according to intention-to- treat; (6) estimate incremental cost effectiveness ratios for experimental arms and perform extensive sensitivity analyses. SCD-HeFT proposes a bold new approach to sudden death prevention as a primary prevention problem. However, the intervention strategies being tested have the potential for both significant beneficial and significant adverse clinical and quality of life effects. In addition, both involve increased health care costs. If efficacy is demonstrated for the primary clinical endpoint (all-cause mortality), then these economics and quality of life data will clearly be pivotal in determining how the results of this study are viewed and whether the superior therapeutic strategy (or strategies) receive widespread implementation. We propose to use stat-of-the-art methods for measuring cost and quality of life and for estimating cost effectiveness. This is a revised submission of HL55496-01.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL055496-01A1
Application #
2457206
Study Section
Special Emphasis Panel (ZHL1-CCT-H (M1))
Project Start
1997-05-01
Project End
2003-04-30
Budget Start
1997-05-01
Budget End
1998-04-30
Support Year
1
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
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
Levy, Wayne C; Lee, Kerry L; Hellkamp, Anne S et al. (2009) Maximizing survival benefit with primary prevention implantable cardioverter-defibrillator therapy in a heart failure population. Circulation 120:835-42
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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