Clinical trial NCT00318357: CARE-HF Long Term Follow-up
Official title: CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Cardiac Resynchronization therapy (CRT)
All-cause mortality
Long-term follow-up
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2006-04-26
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All Cause Mortality
timeFrame: 8-year
Secondary outcomes:
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Hull Royal Infirmary - Academic Cardiology Unit
state: Kingston-Upon-Hull
Study officials:
affiliation: The University of Hull; Department of Cardiology; United Kingdom
name: John Cleland, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.