CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-Term Follow-up
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Device: Medtronic CRT InSync® family devices |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-Term Follow-up |
- All cause Mortality [ Time Frame: 4-year ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
No biospecimens are retained
| Estimated Enrollment: | 550 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
CRT
In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.
|
Device: Medtronic CRT InSync® family devices
Implantation of CRT device and medical treatment according normal hospital routine.
Other Name: Resynchronisation system of the InSync® family
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Chronic heart failure patients with NYHA class III-IV,with a LVEF of less than or equal to 35%, who are on optimal medical treatment, and documented evidence of ventricular dyssynchrony as evidenced by QRS or Echo prior enrollment in the CARE-HF main study.
Patients who have participated in the CARE-HF program and were reported to be alive in May 2005 (study closure of the main study) are asked to participate in the CARE-HF LTFU study.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who have not participated in the CARE-HF program
- Patients with exclusion criteria required by local legislation
Contacts and Locations| United Kingdom | |
| Hull Royal Infirmary - Academic Cardiology Unit | |
| Cottingham, Kingston-Upon-Hull, United Kingdom, HU16 5JQ | |
| Study Chair: | John Cleland, Professor | The University of Hull; Department of Cardiology; United Kingdom |
More Information
No publications provided
| Responsible Party: | Monique Marijianowski, PhD, Medtronic |
| ClinicalTrials.gov Identifier: | NCT00318357 History of Changes |
| Other Study ID Numbers: | CARE-HF Long-term follow-up |
| Study First Received: | April 25, 2006 |
| Last Updated: | May 30, 2008 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Medtronic Bakken Research Center:
|
Cardiac Resynchronization therapy (CRT) All-cause mortality Long-term follow-up |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013