DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE).
The DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) was a multi-center, randomized, investigator-initiated trial. Patients enrolled in the trial had non-ischemic cardiomyopathy (LVEF <or=35%), a history of symptomatic heart failure and spontaneous arrhythmia (>10 PVCs/hr or non-sustained ventricular tachycardia defined as 3 to 15 beats at a rate of >120 bpm) on Holter monitor or telemetry within the past 6 months. All patients received standard oral medical therapy for heart failure including angiotensin converting enzyme inhibitors and beta-blockers. Patients were randomized to implantable cardioverter defibrillator (ICD) versus no ICD. Patients were followed for 2 to 3 years. The primary endpoint was total mortality. Quality of life and pharmacoeconomics analysis was also performed. A registry tracked patients who met basic inclusion criteria but were not randomized. We estimated an annual total mortality of 15% at 2 years in the treatment arm that did not receive an ICD. The ICD was expected to reduce mortality by 50%. Approximately 229 patients were required in each treatment group. Forty-five centers were included in this trial that was designed to last an estimated 4 years. Enrollment was projected to occur over 2 1/2 years with a post enrollment follow-up of 1 1/2 years.
Schaechter
Andi
A
Division of Cardiology, Department of Medicine, Northwestern University Medical School, Chicago, IL, USA.
Kadish
Alan H
AH
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002311:Cardiomyopathy, Dilated / Q000401:mortality*; D017147:Defibrillators, Implantable; D005069:Evaluation Studies as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D018487:Ventricular Dysfunction, Left / Q000401:mortality*
D000806:Angiotensin-Converting Enzyme Inhibitors