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Veterans Affairs congestive heart failure antiarrhythmic trial . CHF STAT Investigators . This is a prospective , double-blind , placebo-controlled trial to determine the effect of antiarrhythmic drug therapy on mortality in patients with congestive heart failure and ventricular arrhythmia . Patients will be assigned to receive either amiodarone or placebo . Eligible patients include those with ischemic and nonischemic congestive heart failure and with > or = 10 ventricular premature beats per hour . All patients must have shortness of breath with minimal exertion or paroxysmal nocturnal dyspnea , a left ventricular internal dimension ( LVIDd ) by echocardiogram of > or = 55 mm or a cardiothoracic ratio of > 0.5 and an ejection fraction of < or = 40 % . All patients will receive vasodilator therapy , unless they find it intolerable . Patients will be entered into the study for 2.5 years and followed for an additional 2 years . Drug therapy will be continued for all patients throughout the entire study unless adverse reactions occur that necessitate individualized treatment . The expectation is that 674 patients will be entered into the study from 25 participating centers . This sample size will allow for the detection of a 33 % decrease in 2-year mortality ( 20 % vs 30 % ) in the treated patients compared with those in the placebo group , with a power of 0.90 and a 2-sided alpha level of 0.05 . Intermittent Holter monitoring , radionuclide ventriculograms , pulmonary function tests , echocardiograms , and blood tests , including arterial blood gases , will be required for each patient . ( ABSTRACT TRUNCATED AT 250 WORDS )
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Intervention_Pharmacological
amiodarone
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Intervention_Control
placebo
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Outcome_Mortality
mortality
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Outcome_Mortality
2-year mortality
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Participant_Age
Veterans
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Participant_Condition
congestive heart failure
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Participant_Condition
congestive heart failure
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Participant_Condition
ventricular arrhythmia
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Participant_Condition
congestive heart failure
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Participant_Condition
ventricular premature beats
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Participant_Condition
shortness of breath
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Participant_Condition
paroxysmal nocturnal dyspnea