NCT00318357

CARE-HF Long Term Follow-up

CARE-HF LTFU: CArdiac REsynchronization in Heart Failure Long-term Follow-up

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Continuation of CRT	Implantation of CRT device and medical treatment according normal hospital routine.
DEVICE	Upgrade to CRT	Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2006-04-26
• Last updated: 2025-07-02
• Results posted: 2019-06-26

Locations

1 site across 1 country: United Kingdom