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Completed

NCT Number: NCT01091441

Permanent Observatory of Heart Failure

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.

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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brabois-Nancy University Hospital

Vandœuvre-lès-Nancy, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Event-free survival

    Time frame: 2 years

    To analyse survival after 2 years of follow-up (all-causes death)

Secondary outcomes

  1. Recurrence of heart failure

    Time frame: 2 years

    Analyze the data of disease: recurrence of heart failure

  2. Therapeutic

    Time frame: 2 years

    Analyze the data of disease: therapeutic took 2 years of follow-up

  3. Number of participants with adverse events

    Time frame: 2 years

    Analyze the data of disease: cardiovascular events or other non-cardiovascular

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: ODIN

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Mar 24, 2010
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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