CARE-HF Long Term Follow-up

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Upgrade to CRT; Device: Continuation of CRT

Study type: Observational

Funder types: Industry

Identifiers

NCT00318357

CARE-HF Long-term follow-up

Details and patient eligibility

About

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.

Full 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.

Enrollment: 309 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

309 participants in 2 patient groups

CRT in CARE-HF

Description:

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.

Treatment:

Device: Continuation of CRT

Control in CARE-HF

Description:

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.

Treatment:

Device: Upgrade to CRT