Permanent Observatory of Heart Failure (ODIN)
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|ClinicalTrials.gov Identifier: NCT01091441|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : November 24, 2017
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 or disease|
|Acute Heart Failure|
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.
|Study Type :||Observational|
|Actual Enrollment :||3248 participants|
|Official Title:||Permanent Observatory of Heart Failure|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Patients with heart failure
Patients hospitalized for acute heart failure
- Event-free survival [ Time Frame: 2 years ]To analyse survival after 2 years of follow-up (all-causes death)
- Recurrence of heart failure [ Time Frame: 2 years ]Analyze the data of disease: recurrence of heart failure
- Therapeutic [ Time Frame: 2 years ]Analyze the data of disease: therapeutic took 2 years of follow-up
- Number of participants with adverse events [ Time Frame: 2 years ]Analyze the data of disease: cardiovascular events or other non-cardiovascular
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091441
|Brabois-Nancy University Hospital|
|Vandoeuvre les Nancy, France, 54500|