CARE-HF Long Term Follow-up

Completed

• Conditions: Heart Failure
• Interventions: Device: Upgrade to CRT; Device: Continuation of CRT

• Registration Number: NCT00318357
• Lead Sponsor: Medtronic Bakken Research Center

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
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2017-11-13
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-01
• Last Update Submitted: 2019-04-01
• Results First Posted: 2019-06-26
• Last Update Posted: 2019-06-26

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

Arm && Interventions

Group	Intervention	Description
Control in CARE-HF	Upgrade to CRT	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.
CRT in CARE-HF	Continuation of CRT	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.

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