CARE-HF Long Term Follow-up

Completed

• 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.

Study Timeline

• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Study Start: 2006-09-01
• Primary Completion: 2010-09
• Study Completion: 2010-09-01
• Results First Submitted: 2017-11-13
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-01
• Results First Posted: 2019-06-26
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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

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.

Trial Locations

Locations (1)

Hull Royal Infirmary - Academic Cardiology Unit; 🇬🇧 Cottingham, Kingston-Upon-Hull, United Kingdom