Permanent Observatory of Heart Failure (ODIN)
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Purpose
The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated. Patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
The following of patients will be periodic after their entry in the observatory, up to 2 years of follow up.
| Condition |
|---|
|
Acute Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Permanent Observatory of Heart Failure |
- Event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To analyse survival after 2 years of follow-up (all-causes death)
- Recurrence of heart failure [ Time Frame: 2 years ] [ Designated as safety issue: No ]Analyze the data of disease: recurrence of heart failure
- Therapeutic [ Time Frame: 2 years ] [ Designated as safety issue: No ]Analyze the data of disease: therapeutic took 2 years of follow-up
- Number of participants with adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]Analyze the data of disease: cardiovascular events or other non-cardiovascular
| Enrollment: | 3248 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Patients with heart failure
Patients hospitalized for acute heart failure
|
Detailed Description:
The Center for patients with heart failure cared for in a center practicing therapeutic education dedicated to heart failure.
The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology : presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure.
All patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated.
All patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
Follow up is done by CRAs at the French Society of Cardiology, by mailing and phone contacts.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All patients with heart failure in France
The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology (The Task Force for the Diagnosis and Treatment of Congestive Heart Failure of the European Society of Cardiology. Eur Heart J 2005; 26: 1115 -- 1140): presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure
Inclusion Criteria:
- Patient with heart failure
- Patient supported by a center participating in the I-CARE french program
Exclusion Criteria:
- Refusal by the patient to be listed in an observatory
Contacts and Locations More Information
No publications provided
| Responsible Party: | Juilliere, Professor, French Cardiology Society |
| ClinicalTrials.gov Identifier: | NCT01091441 History of Changes |
| Other Study ID Numbers: | 06302 |
| Study First Received: | March 18, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | France : National Commission on Informatics and Freedoms |
Keywords provided by French Cardiology Society:
|
therapeutic education |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013