Trial-Results center  
Clinical trial results database in 100 Feedback    Home


Related trials

REVERSE, 2008 - CRT vs no CRT

RethinQ, 2007 - Combined CRT + ICD vs no CRT

CARE-HF, 2005 - CRT vs no CRT

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

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

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

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

PATH-CHF, 2002 - 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

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
  •  

    MIRACLE study, 2002

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

    Treatments

    Studied treatment CRT Medtronic
    Control treatment CRT off
    Concomittant treatment without a combined defibrillator function

    Patients

    Patients patients with moderate-to-severe symptoms of heart failure associated with an ejection fraction of 35 percent or less and a QRS interval of 130 msec
    Inclusion criteria NYHA III >=1 month,EF<=35%,LVEDD >=55 mm,QRS >=130 ms,6 min-walk < 450 m
    Baseline characteristics
    Age (mean), years 64 y 
    Men (%) 68% 
    Ischaemic cause (%) 54% 
    NYHA III (%) 91% 
    LVEF (mean), % 22% 
    QRS duration (mean), ms 166 
    beta-blocker use (%) 59% 
    ACE-I or ARB use (%) 92% 
    Spironolactone use (%) NA 
    Blinding endpoint comittee Blinded 
    NYHA III/IV (%) 100% 

    Method and design

    Randomized effectives 228 / 225 (studied vs. control)
    Design Parallel groups
    Blinding Bouble blind
    Follow-up duration 6 months
    Primary endpoint New York Heart Association functional class


    Results

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

    All cause death

    12 / 228
    16 / 225
    0,74 [0,36;1,53]

    Sudden death

    7 / 263
    5 / 269
    classic 1,43 [0,46;4,46]

    heart failure death

    4 / 263
    10 / 269
    0,41 [0,13;1,29]

    hospitalisation for heart failure

    18 / 228
    34 / 225
    0,52 [0,30;0,90]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 12 / 228 (5,3%) 16 / 225 (7,1%) 0,74 [0,36;1,53]   0
    Sudden death 7 / 263 (2,7%) 5 / 269 (1,9%) 1,43 [0,46;4,46]  
    heart failure death 4 / 263 (1,5%) 10 / 269 (3,7%) 0,41 [0,13;1,29]  
    hospitalisation for heart failure 18 / 228 (7,9%) 34 / 225 (15,1%) 0,52 [0,30;0,90]   0
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 5,26% 7,11% -18,5‰
    Sudden death 2,66% 1,86% 8,0‰
    heart failure death 1,52% 3,72% -22,0‰
    hospitalisation for heart failure 7,89% 15,11% -72,2‰

    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
    • Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J. Cardiac resynchronization in chronic heart failure.. N Engl J Med 2002;346:1845-53
      Pubmed | Hubmed | Fulltext
    • Barold H.. Preliminary clinical review of Medtronic’s InSync MIRACLE PMA (Report). http://www.fda.gov/cdrh/pdf/p010015.html. (26 September 2005).\
      Pubmed | Hubmed | Fulltext

    (c) 2004-2014 TrialResults-center - All Rights Reserved

    Tweet this  |  Facebook  |  notify a friend

    100100