Permanent Observatory of Heart Failure (ODIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juilliere, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01091441
First received: March 18, 2010
Last updated: July 8, 2014
Last verified: July 2014
  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

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To analyse survival after 2 years of follow-up (all-causes death)


Secondary Outcome Measures:
  • 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
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091441

Locations
France
Brabois-Nancy University Hospital
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
French Cardiology Society
  More Information

Publications:
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: July 8, 2014
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 September 14, 2014