CARE-HF Long Term Follow-up
- Conditions
- Heart Failure
- Registration Number
- NCT00318357
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Brief Summary
The CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.
- Detailed Description
The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, and UK). All patients that were reported to be alive in May 2005 will be asked to participate.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 309
- Patients who have participated in the CARE-HF program and were reported to be alive in May 2005
- Patients who signed a patient data release consent form
- Patients who have not participated in the CARE-HF program
- Patients with exclusion criteria required by local legislation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All Cause Mortality 8-year Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial.
The patients that were still alive after closure of the CARE-HF study (2005,NCT00170300), that were willing to participate in the CARE-HF LTFU study continued additional follow-up for 4 years, till end 2009. The reported mortality data is the combined mortality of the CARE-HF and the CARE-HF LTFU study. Study start CARE-HF 2000.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
Hull Royal Infirmary - Academic Cardiology Unit
🇬🇧Cottingham, Kingston-Upon-Hull, United Kingdom
Hull Royal Infirmary - Academic Cardiology Unit🇬🇧Cottingham, Kingston-Upon-Hull, United Kingdom