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Study Facts
Study Design
Milestones
Study Design
All 2,521 patients participating in this three-arm, randomized, longitudinal trial had:
- Congestive heart failure (CHF), New York Heart Association [NYHA Class II or III] and
- reduced left ventricular ejection fraction (LVEF) < 35%
Such individuals are at risk of developing dangerously fast heart rhythms, such as ventricular fibrillation (VF) or ventricular tachycardia (VT), that can lead to sudden cardiac arrest (SCA) and death (SCD).1
All patients received conventional optimal medical therapy for heart failure (including angiotensin converting enzyme [ACE] inhibitors). In addition, patients were allocated in equal proportions to one of three different treatment arms:
- Conventional therapy + placebo (control group)
- Conventional therapy + amiodarone
- Conventional therapy + single chamber ICD
The primary, specific aim of the study was to compare all-cause mortality in the three arms of the study after a minimum of 30 months (2.5 years) follow-up. [More] |
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Inclusion criteria
The study participants met the following inclusion criteria:
- LVEF < 35%
- Symptomatic CHF (NYHA Class II and III) due to ischemic or non-ischemic dilated cardiomyopathy
- > 18 years of age, no upper age limitation
- CHF present for at least 3 months prior to randomization
- Receiving appropriate dose of ACE inhibitor (e.g., enalapril 10 mg bid)
- Receiving beta-blocker therapy, if tolerated (e.g., carvedilol 25 mg bid)
- Coronary arteriography, if clinically reasonable
- Patients with chronic AF must be anticoagulated (INR > 2.0 for > 3 weeks)
- Females must be free from risk of pregnancy and have a negative serum pregnancy test.
Exclusion criteria
Patients were permanently excluded from the study according to these criteria:
- NYHA Class I or IV CHF on the day of randomization
- History of spontaneous sustained VT/VF not associated with an acute Q-wave MI
- Unexplained syncope within 5 years
- Expected cardiac transplantation within 2 years
- Contraindication of Amiodarone for any reason
- AF likely to require Amiodarone or ablation of the AV node for rate control
- Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, myocarditis, complex congenital disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease
- Life expectancy of < 1 year, from any cause
- Mechanical prosthetic cardiac valves
- Major psychiatric disorder, active alcohol/drug abuse, and/or history of non-compliance
- Current Class I or III antiarrhythmic drug therapy
- Concomitant participation in another mortality end point clinical trial
- Inability to accommodate left sided ICD
- Pacemaker therapy
- Liver enzyme tests > 2.5 times normal or a serum Cr > 2.5 mg/dl
- Inability to provide informed consent
In addition to these permanent exclusion criteria, there were several temporary exclusion criteria: [More]
1Bardy, GH. The Sudden Cardiac Death–Heart Failure Trial (SCD-HeFT). In: Arrhythmia Treatment and Therapy: Evaluation of Clinical Trial Evidence. Eds: Woosley, RL and Singh, SN. 2000, 323-342.
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