Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
309 participants
OBSERVATIONAL
2006-09-30
2010-09-30
Brief Summary
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Detailed Description
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In the CARE-HF LTFU program patients from the CARE-HF trial were asked to be enrolled for an additional 4 year follow-up. Investigators were free to choose whatever available treatment they believe is in the patient's best interest, however the outcome of the CARE-HF trial suggested that all patients should receive CRT therapy on top of Optimal Medical Treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CRT in CARE-HF
In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.
CARE-HF LTFU study continued ot follow up the original CARE-HF CRT group patients.
Continuation of CRT
Implantation of CRT device and medical treatment according normal hospital routine.
Control in CARE-HF
In the CARE-HF study patients treated with standard medical treatment. In the CARE-HF Long Term Follow-up part, almost all patients received CRT therapy on top of Optimal Medical Treatment. The CARE-HF LTFU study aims to further investigate mortality.
CARE-HF LTFU study continued to follow up the original CARE-HF control group patients.
Upgrade to CRT
Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
Interventions
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Continuation of CRT
Implantation of CRT device and medical treatment according normal hospital routine.
Upgrade to CRT
Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who signed a patient data release consent form
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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John Cleland, Professor
Role: STUDY_CHAIR
The University of Hull; Department of Cardiology; United Kingdom
Locations
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Hull Royal Infirmary - Academic Cardiology Unit
Cottingham, Kingston-Upon-Hull, United Kingdom
Countries
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References
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Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Klein W, Tavazzi L; CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Eur J Heart Fail. 2001 Aug;3(4):481-9. doi: 10.1016/s1388-9842(01)00176-3.
Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7.
Cleland JG, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC. Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. Eur J Heart Fail. 2012 Jun;14(6):628-34. doi: 10.1093/eurjhf/hfs055. Epub 2012 May 2.
Other Identifiers
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CARE-HF Long-term follow-up
Identifier Type: -
Identifier Source: org_study_id
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