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Related trials

REVERSE, 2008 - CRT vs no CRT

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SCD-HeFT (ICD vs placebo), 2005 - ICD vs no ICD

SCD-HeFT (ICD vs amiodarone), 2005 - ICD vs no ICD

CARE-HF, 2005 - CRT vs no CRT

DEFINITE, 2004 - ICD vs no ICD

DINAMIT, 2004 - ICD vs no ICD

COMPANION (CRT+ICD vs MT), 2004 - Combined CRT + ICD vs no CRT no ICD

COMPANION (CRT vs MT), 2004 - CRT vs no CRT

MIRACLE-ICD-II, 2004 - Combined CRT + ICD vs ICD alone

COMPANION (CRT+ICD vs CRT), 2004 - Combined CRT + ICD vs CRT

MIRACLE-ICD-I, 2003 - Combined CRT + ICD vs ICD alone

CONTAK-CD , 2003 - Combined CRT + ICD vs ICD alone

AMIOVIRT, 2003 - Combined CRT + ICD vs no CRT no ICD

RD-CHF, 2003 - CRT vs no CRT

Garrigue, 2002 - CRT vs no CRT

MIRACLE, 2002 - CRT vs no CRT

CAT, 2002 - ICD vs no ICD

MUSTIC AF, 2002 - CRT vs no CRT

MADIT-II, 2002 - ICD vs no ICD

PATH-CHF, 2002 - CRT vs no CRT

MUSTIC-SR, 2001 - CRT vs no CRT

MUSIT, 1999 - ICD vs no ICD

CABG-patch, 1997 - ICD vs no ICD

MADIT, 1996 - ICD vs no ICD



See also:

  • All heart failure clinical trials
  • All prevention of sudden death clinical trials
  • All clinical trials of resynchronization (CRT) - defibrillators (ICD)
  • All clinical trials of CRT
  •  

    CARE-HF study, 2005

    download pdf: CRT | resynchronization (CRT) - defibrillators (ICD) for heart failure

    Treatments

    Studied treatment CRT medtronic
    Control treatment no CRT
    Concomittant treatment without a combined defibrillator function

    Patients

    Patients patients with NYHA class III or IV heart failure due to left ventricular systolic dysfunction and cardiac dyssynchrony
    Inclusion criteria NYHA III andIV >= 6 weeks,EF <=35%,QRS >=120 ms,(QRS 120–149 ms,mechanicaldyssynchronyrequired)
    Baseline characteristics
    Age (mean), years 67  
    Men (%) 74 
    Ischaemic cause (%) 38%  
    NYHA III (%) 94%  
    LVEF (mean), % 25%  
    QRS duration (mean), ms 160 
    beta-blocker use (%) 72%  
    ACE-I or ARB use (%) 95%  
    Spironolactone use (%) 55 
    Blinding endpoint comittee Blinded 

    Method and design

    Randomized effectives 409 / 404 (studied vs. control)
    Design parallel group
    Blinding open
    Follow-up duration 29.4 months
    Primary endpoint deat or hospitalization


    Results

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    heart failure death

    33 / 409
    56 / 404
    0,58 [0,39;0,87]

    hospitalisation for heart failure

    72 / 409
    133 / 404
    0,53 [0,42;0,69]

    All cause death

    82 / 409
    120 / 404
    0,67 [0,53;0,86]

    Sudden death

    29 / 409
    38 / 404
    0,75 [0,47;1,20]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    heart failure death 33 / 409 (8,1%) 56 / 404 (13,9%) 0,58 [0,39;0,87]  
    hospitalisation for heart failure 72 / 409 (17,6%) 133 / 404 (32,9%) 0,53 [0,42;0,69]   14384
    All cause death 82 / 409 (20,0%) 120 / 404 (29,7%) 0,67 [0,53;0,86]   0
    Sudden death 29 / 409 (7,1%) 38 / 404 (9,4%) 0,75 [0,47;1,20]  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:
  • 14384: Al-Majed NS, McAlister FA, Bakal JA, Ezekowitz JAMeta-analysis: Cardiac Resynchronization Therapy for Patients With Less Symptomatic Heart Failure.Ann Intern Med 2011;154:401-12

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    heart failure death 8,07% 13,86% -57,9‰
    hospitalisation for heart failure 17,60% 32,92% -153,2‰
    All cause death 20,05% 29,70% -96,5‰
    Sudden death 7,09% 9,41% -23,2‰

    Meta-analysis of all similar trials:

    resynchronization (CRT) - defibrillators (ICD) in heart failure for all type of patients

    resynchronization (CRT) - defibrillators (ICD) in prevention of sudden death for primary prevention

    resynchronization (CRT) - defibrillators (ICD) in prevention of sudden death for heart failure



    Reference(s)

    Trials register # NA
    • Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L. The effect of cardiac resynchronization on morbidity and mortality in heart failure.. N Engl J Med 2005;352:1539-49
      Pubmed | Hubmed | Fulltext

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