The study involved 2,521participants, who were randomly assigned to one of three treatment arms--847 in a placebo group, 845 in the amiodarone group, and 829 in the ICD group. The mean follow-up was almost 4 years.
Patient enrollment began in September 1997 and patient follow-up ended in October 2003. Participants were enrolled through 148 hospitals, clinics, and academic centers in the United States, Canada, and New Zealand. The study's Clinical Coordinating Center is at the Seattle Institute for Cardiac Research; the Data Coordinating Center is at the Duke Clinical Research Institute at Duke University in Durham, NC. The study biostatistician is Dr. Kerry Lee, Director of Biostatistics at Duke Clinical Research Institute. The participants had moderate to severe heart failureNew York Heart Association classes II and III. Classes range from I to IV. Class II patients have trouble breathing or feel tired after exercise, such as climbing stairs; class III patients have such heart failure symptoms while performing minimal activities, such as walking on level ground.
Study participants ranged in age from 19 to 90; the median age was 60. Seventy-seven percent were men and 23 percent women. Seventy-seven percent were white, 17 percent African American, and about 6 percent other minorities.
Fifty-two percent had heart failure caused by heart attack (myocardial infarction) and 48 percent had heart failure due to a different cause, such as a viral infection of the heart. Thirty percent had diabetes and 15 percent had had at least one episode of diagnosed atrial fibrillation when they entered the study.
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NIH/National Heart, Lung, and Blood Institute
8-Mar-2004