Heart Failure
Conditions
Keywords
Cardiac Resynchronization therapy (CRT), All-cause mortality, Long-term follow-up
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.
Interventions
DEVICEContinuation of CRT
Implantation of CRT device and medical treatment according normal hospital routine.
DEVICEUpgrade to CRT
Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine.
Sponsors
Medtronic
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Patient alive from original CARE-HF study consented for long term follow-up
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Resynchromization Therapy (Control Pts in CARE-HF) 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. With a recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine. | 136 |
| Cardiac Resynchromization Therapy In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment.
Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine. | 173 |
| Total | 309 |
Baseline characteristics
| Characteristic | Cardiac Resynchromization Therapy (Control Pts in CARE-HF) | Cardiac Resynchromization Therapy | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 65 years | 65 years |
| NYHA functional class III | 132 participants | 165 participants | 297 participants |
| QRS | 160 ms | 160 ms | 160 ms |
| Sex: Female, Male Female | 39 Participants | 45 Participants | 84 Participants |
| Sex: Female, Male Male | 97 Participants | 128 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 39 / 173 | 32 / 136 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
All Cause Mortality
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.
Time frame: 8-year
Population: Data from the CARE-HF and CARE-HF Long-Term Follow-Up studies were combined for analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cardiac Resynchronization Therapy | All Cause Mortality | 54.8 percentage of participants |
| Upgrade to Cardiac Resynchronization Therapy | All Cause Mortality | 64.8 percentage of participants |
Comparison: Mortality is compared between the arms of the CARE-HF study, using Cox proportional hazards regression. Data from the original CARE-HF trial and the CARE-HF Long Term Follow-up trial were combined for the analysis.p-value: 0.007Regression, Cox