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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-40
Application #
6566944
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2001-12-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2002
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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