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Inclusion Criteria
- Symptomatic CHF at enrollment (NYHA Class II or III) due to ischemic or non-ischemic dilated cardiomyopathy.
- LVEF must be <35% as measured by nuclear imaging, catheterization, or echo within 6 months of enrollment.
- CHF must be present for at least 3 months prior to randomization and treated with a vasodilator.
Less than ideal doses of ACEI and beta blockers are approved as long as target doses are attained
shortly after randomization.
- All patients are requested, but not required, to have had a coronary angiogram to document the nature of their disease.
The definition of ischemic cardiomyopathy will be systolic LV disfunction in the presence of <75%
luminal coronary artery or insignificant coronary artery disease with definitive evidence of MI.
Patients with ischemic cardiomyopathy who have not had a coronary angiography within three years of enrollment
should have clinical findings consistent with stable coronary artery disease prior to inclusion into the study.
- All patients with chronic atrial fibrillation must be anticoagulated with documented INRs of at least 2.0 for at least 21 days prior to enrollment.
- If female, the patient is post-menopausal, surgically sterile or using adequate contraception and has a negative serum pregnancy test within the week prior to
enrollment and has no intentions of becoming pregnant.
- The 6 minute walk must be done at the time of enrollment unless the patient is unable to walk due to amputation, stroke, or other disability
- A 24 hour Holter monitor recording (unread) must be done within 1 week prior to randomization.
- A 12-lead ECG must be obtained immediately prior to enrollment.
Exclusion Criteria
- Cardiac arrest or an episode of sustained VT (defined as VT persisting for more than 30 seconds at rates >100 bpm) not associated with an acute Q-wave MI.
- Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, myocarditis, congenital heart disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease.
- Younger than 18 years of age.
- Life expectancy of less than one year from any non-cardiac cause.
- Expected cardiac transplantation within one year.
- Major psychiatric disorder, active alcohol/drug abuse, and/or non-compliance.
- Contraindication of amiodarone for any reason.
- Current amiodarone therapy.
- Current antiarrhythmic drug therapy (Class I or III) other than calcium blockers, beta blockers, or digoxin.
- Atrial fibrillation requiring amiodarone therapy or catheter ablation of the atrioventricular conduction system for rate control.
- Pacemaker.
- History of unexplained syncope within the last 5 years.
- Inability to accommodate ICD placement in the left infraclavicular region.
- Mechanical prosthetic cardiac valves.
- Liver function studies at least 2.5 times normal or a serum creatinine >2.5 mg/dl.
- Concomitant participation in any investigational clinical trial.
- Inability to provide informed consent.
Temporary Exclusion Criteria
- Any cardiac surgery or catheter revascularization (angioplasty, stent or atherectomy) myocardial infarction, unstable angina, or CVA within 30 days.
- Atrial fibrillation/flutter and an uncontrolled ventricular rate defined as an average resting ventricular rate >120 bpm.
- New onset AF at time of enrollment.
- CHF for less than 3 months.
- Current antibiotic therapy.
Last updated April 18, 2000
Please send questions or comments to:
sicr@sicr.org
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