Sudden cardiac death in heart failure trial of prophylactic amiodarone or defibri

Case Western Reserve University, Cleveland OH

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Abstract

Congestive heart failure is a common and lethal disease. Patients with moderate left ventricular dysfunction have a 25% mortality over 2.4 years. Fifty percent of these deaths are sudden and presumed arrhythmias in the majority of these sudden deaths. The hypothesis of this study is that Amiodarone or an implantable cardioverter-defibrilator will improve survival compared to placebo in patients with New York Heart Association Class II or III congestive heart failure and a left ventricular ejection fraction of less that or equal to 35%. This is a three arm study. Patients ramdomized to the first arm, "Conventional therapy", will receive standard CHF therapy including ACE inhibitors. The second arm, "Amiodarone vs. placebo", will be randomized to receive amiodarone vs. placebo. The third arm is, "implantable cardioverter-defibrillator (ICD)". Patients in this limb will receive a single lead device which will monitor for ventricular arrhythmias and will deliver a high voltage shock to return the rhythm to the normal one. This study may allow primary prevention of arrhythmic death in patients at high risk of this problem: patients with congestive heart failure.