Permanent Observatory of Heart Failure

Completed

• Conditions: Acute Heart Failure

• Registration Number: NCT01091441
• Lead Sponsor: French Cardiology Society

Brief Summary

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.

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3248

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free survival	2 years	To analyse survival after 2 years of follow-up (all-causes death)

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	2 years	Analyze the data of disease: cardiovascular events or other non-cardiovascular
Recurrence of heart failure	2 years	Analyze the data of disease: recurrence of heart failure
Therapeutic	2 years	Analyze the data of disease: therapeutic took 2 years of follow-up

Trial Locations

Locations (1)

Brabois-Nancy University Hospital; 🇫🇷 Vandoeuvre les Nancy, France