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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT in CARE-HF | 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. |
| |
| Control 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuation of CRT | Device | Implantation of CRT device and medical treatment according normal hospital routine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8-year |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic heart failure patients with NYHA class III-IV,with a LVEF of less than or equal to 35%, who are on optimal medical treatment, and documented evidence of ventricular dyssynchrony as evidenced by QRS or Echo prior enrollment in the CARE-HF main study.
Patients who have participated in the CARE-HF program and were reported to be alive in May 2005 (study closure of the main study) are asked to participate in the CARE-HF LTFU study.
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| Name | Affiliation | Role |
|---|---|---|
| John Cleland, Professor | The University of Hull; Department of Cardiology; United Kingdom | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull Royal Infirmary - Academic Cardiology Unit | Cottingham | Kingston-Upon-Hull | HU16 5JQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11511435 | Background | Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Klein W, Tavazzi L; CARE-HF study Steering Committee and Investigators. The CARE-HF study (CArdiac REsynchronisation in Heart Failure study): rationale, design and end-points. Eur J Heart Fail. 2001 Aug;3(4):481-9. doi: 10.1016/s1388-9842(01)00176-3. | |
| 15753115 |
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Patient alive from original CARE-HF study consented for long term follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Cardiac Resynchromization Therapy (Control Pts in CARE-HF | In the CARE-HF study patients treated with standard medical treatment plus CRT were compared to patients treated with standard medical treatment. After release Medtronic CRT InSync® family devices : Implantation of CRT device and medical treatment according normal hospital routine. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data from the CARE-HF and CARE-HF Long-Term Follow-Up studies were combined for analysis | Posted | Number | percentage of participants | 8-year |
|
8-year. 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.During the CARE-HFF LTFU study only mortality data was collected, no other adverse event data was collected..
No Serious Adverse Events or Adverse events were collected during the CARE-HF LTFU study.
All-Cause Mortality was monitored/assessed. Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac REsynchronization Therapy | 39 | 173 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Cleland, Professor | The University of Hull; Department of Cardiology; United Kingdom | Telephone: 0044 1482 624084 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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No biospecimens are retained
| Upgrade to CRT | Device | Recommended implantation of a Medtronic CRT InSync® family devices. Implantation of CRT device and medical treatment according normal hospital routine. |
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| Cleland JG, Daubert JC, Erdmann E, Freemantle N, Gras D, Kappenberger L, Tavazzi L; Cardiac Resynchronization-Heart Failure (CARE-HF) Study Investigators. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005 Apr 14;352(15):1539-49. doi: 10.1056/NEJMoa050496. Epub 2005 Mar 7. |
| 22552183 | Result | Cleland JG, Freemantle N, Erdmann E, Gras D, Kappenberger L, Tavazzi L, Daubert JC. Long-term mortality with cardiac resynchronization therapy in the Cardiac Resynchronization-Heart Failure (CARE-HF) trial. Eur J Heart Fail. 2012 Jun;14(6):628-34. doi: 10.1093/eurjhf/hfs055. Epub 2012 May 2. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| NYHA functional class III | New York Heart Association (NYHA) functional classification. It places patients in one of four catagories based on how much they are limited during physical activity. NYHA class III patient symptoms: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. | Number | participants |
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| QRS | Median | Inter-Quartile Range | ms |
|
| OG001 | Upgrade to Cardiac Resynchronization Therapy | 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. |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Upgrade to Cardiac Resynchronization Therapy | 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. | 32 | 136 | 0 | 0 | 0 | 0 |
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