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.
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