MIRACLE-ICD-I, 2003 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of Combined CRT + ICD versus ICD alone in patients with NYHA class III or IV congestive HF despite appropriate medical management

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JAMA 2003;289:2685-94  



Studied treatment ICD+CRT (plus optimal medical treatment)
Control treatment ICD (plus optimal medical treatment)
Age (mean), years 67 y
Men (%) 81%



Patients patients with NYHA class III or IV congestive HF despite appropriate medical management
Group sizes187 / 182
Ischaemic cause (%) 70%
beta-blocker use (%) 60%
ACE-I or ARB use (%) 91%
Spironolactone use (%)
Blinding endpoint comittee
nonischemic cardiomyopathy '%)



Blindness double blind Inclusion period Oct 1999-Aug 2001
Follow-up duration 6 months Centers
Lost to FU geographical localisation
Primary endpoint none Design Parallel groups
PeriodeInclusionOct 1999-Aug 2001
duration of CHD



EndpointX1N1X0N0TE95% CI death or nonfatal CHF events - 187 - 182 no data sudden cardiac death - 187 - 182 no data All cause death 4 187 5 182 0,78[0,21; 2,95] Heart failure hospitalizations 85 187 78 182 1,06[0,70; 1,60] heart failure death - 187 - 182 no data0,22,01,0

Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA 2003;289:2685-94     [PMID: 12771115]   link to pdf   add to Mendeley  



Registering number (see trial on clinicaltrials.gov)
Code Name