DEFINITE, 2004 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of ICD versus no ICD in patients with non ischemic cardiomyopathy with EF <0.36 and Nonsustained ventricular tachycardia or frequent premature ventricular complexes

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Am Heart J 2008;156:367-72  



Studied treatment ICD
Control treatment no ICD, standard medical therapy
Age (mean), years 58 y
Men (%) 71%
cross over to ICD (%) NA
cross over to medical treatment (%) NA



Patients patients with non ischemic cardiomyopathy with EF <0.36 and Nonsustained ventricular tachycardia or frequent premature ventricular complexes
Group sizes229 / 229
Ischaemic cause (%) 0%
beta-blocker use (%) 85%
ACE-I or ARB use (%) 86% vs 11%
Spironolactone use (%)
Blinding endpoint comittee yes
nonischemic cardiomyopathy '%)



Blindness open Inclusion period 1998-2000
Follow-up duration 29 months Centers
Lost to FU geographical localisation
Primary endpoint Total mortality Design Parallel groups
PeriodeInclusion1998-2000
duration of CHD 2.8 y



EndpointX1N1X0N0TE95% CI death or nonfatal CHF events - 229 - 229 no data Heart failure hospitalizations - 229 - 229 no data All cause death 28 229 40 229 0,70[0,42; 1,18] heart failure death - -9 - -9 no data sudden cardiac death - 229 - 229 no data0,22,01,0

Kadish A, Dyer A, Daubert JP, Quigg R, Estes NA, Anderson KP, Calkins H, Hoch D, Goldberger J, Shalaby A, Sanders WE, Schaechter A, Levine JH Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med 2004;350:2151-8     [PMID: 15152060]   link to pdf   add to Mendeley  

Albert CM, Quigg R, Saba S, Estes NA 3rd, Shaechter A, Subacius H, Howard A, Levine J, Kadish A Sex differences in outcome after implantable cardioverter defibrillator implantation in nonischemic cardiomyopathy. Am Heart J 2008;156:367-72     [PMID: 18657670]   link to pdf   add to Mendeley  



Registering number (see trial on clinicaltrials.gov)
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