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Care-HF CArdiac Resynchronization in Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implantable Cardiac Resynchronisation (pacing) device
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cardiac resynchronisation therapy (CRT therapy),, all-cause mortality,, quality of life assesment,, echocardiographic left ventricular function,, CRT and neurohormonal activation,, CRT and health economics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Heart failure for at least 6 weeks requiring loop diuretics Currently in NYHA class III/IV A high standard of pharmacological therapy LV systolic dysfunction and dilation (EF <=35%; EDD >30mm/height in metres) QRS >=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall) Exclusion Criteria: Age < 18 years old or age < legal age defined in the country in case different Chronic atrial fibrillation within 6 weeks prior to randomization; Impairment of left ventricular function not related to left ventricular systolic function Potentially reversible forms of cardiomyopathy: Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization A conventional indication for bradyarrhythmia pacing exists; A conventional indication for an ICD exists A pacemaker or ICD has already been implanted; In-Patients requiring continuous intravenous therapy for Heart Failure; Life expectancy < 1 year for disease unrelated to Heart Failure; Pregnancy or childbearing potential and not on reliable contraceptive; Mechanical tricuspid valve; Anticipated compliance problem or participation in another trial;

Sites / Locations

    Outcomes

    Primary Outcome Measures

    All cause mortality or unplanned cardiovascular hospitalization.

    Secondary Outcome Measures

    All cause mortality
    All cause mortality or unplanned hospitalization for or with worsening Heart Failure
    Days alive and not in hospital for unplanned cardiovascular cause
    Days alive and not in hospital for any reason
    NYHA class at 90 days
    QOL at 90 days
    End of study status
    MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
    HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    January 29, 2018
    Sponsor
    Medtronic Bakken Research Center
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00170300
    Brief Title
    Care-HF CArdiac Resynchronization in Heart Failure
    Official Title
    Outcome Trial (Long Term)to Evaluate the Effects of Cardiac Resynchronization Therapy on the Mortality and Morbidity of Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medtronic Bakken Research Center
    Collaborators
    Medtronic

    4. Oversight

    5. Study Description

    Brief Summary
    The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.
    Detailed Description
    813 patients enrolled 82 centers in 12 countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    Cardiac resynchronisation therapy (CRT therapy),, all-cause mortality,, quality of life assesment,, echocardiographic left ventricular function,, CRT and neurohormonal activation,, CRT and health economics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    813 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Implantable Cardiac Resynchronisation (pacing) device
    Primary Outcome Measure Information:
    Title
    All cause mortality or unplanned cardiovascular hospitalization.
    Secondary Outcome Measure Information:
    Title
    All cause mortality
    Title
    All cause mortality or unplanned hospitalization for or with worsening Heart Failure
    Title
    Days alive and not in hospital for unplanned cardiovascular cause
    Title
    Days alive and not in hospital for any reason
    Title
    NYHA class at 90 days
    Title
    QOL at 90 days
    Title
    End of study status
    Title
    MECHANISTIC OUTCOME:Echocardiographic parameters, Neurohormonal parameters, Therapy delivery assessment
    Title
    HEALTH ECONOMIC OUTCOME:Cost effectiveness of cardiac resynchronization will be assessed.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Heart failure for at least 6 weeks requiring loop diuretics Currently in NYHA class III/IV A high standard of pharmacological therapy LV systolic dysfunction and dilation (EF <=35%; EDD >30mm/height in metres) QRS >=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall) Exclusion Criteria: Age < 18 years old or age < legal age defined in the country in case different Chronic atrial fibrillation within 6 weeks prior to randomization; Impairment of left ventricular function not related to left ventricular systolic function Potentially reversible forms of cardiomyopathy: Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization A conventional indication for bradyarrhythmia pacing exists; A conventional indication for an ICD exists A pacemaker or ICD has already been implanted; In-Patients requiring continuous intravenous therapy for Heart Failure; Life expectancy < 1 year for disease unrelated to Heart Failure; Pregnancy or childbearing potential and not on reliable contraceptive; Mechanical tricuspid valve; Anticipated compliance problem or participation in another trial;
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Cleland, Professor
    Organizational Affiliation
    The University of Hull; Department of Cardiology; United Kingdom
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35490339
    Citation
    Cleland JGF, Bristow MR, Freemantle N, Olshansky B, Gras D, Saxon L, Tavazzi L, Boehmer J, Ghio S, Feldman AM, Daubert JC, de Mets D. The effect of cardiac resynchronization without a defibrillator on morbidity and mortality: an individual patient data meta-analysis of COMPANION and CARE-HF. Eur J Heart Fail. 2022 Jun;24(6):1080-1090. doi: 10.1002/ejhf.2524. Epub 2022 May 22.
    Results Reference
    derived
    PubMed Identifier
    29314424
    Citation
    Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4.
    Results Reference
    derived
    PubMed Identifier
    23900696
    Citation
    Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29.
    Results Reference
    derived
    PubMed Identifier
    23541971
    Citation
    Damy T, Ghio S, Rigby AS, Hittinger L, Jacobs S, Leyva F, Delgado JF, Daubert JC, Gras D, Tavazzi L, Cleland JG. Interplay between right ventricular function and cardiac resynchronization therapy: an analysis of the CARE-HF trial (Cardiac Resynchronization-Heart Failure). J Am Coll Cardiol. 2013 May 28;61(21):2153-60. doi: 10.1016/j.jacc.2013.02.049. Epub 2013 Mar 26.
    Results Reference
    derived
    PubMed Identifier
    18672164
    Citation
    Cleland J, Freemantle N, Ghio S, Fruhwald F, Shankar A, Marijanowski M, Verboven Y, Tavazzi L. Predicting the long-term effects of cardiac resynchronization therapy on mortality from baseline variables and the early response a report from the CARE-HF (Cardiac Resynchronization in Heart Failure) Trial. J Am Coll Cardiol. 2008 Aug 5;52(6):438-45. doi: 10.1016/j.jacc.2008.04.036.
    Results Reference
    derived

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    Care-HF CArdiac Resynchronization in Heart Failure

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