Permanent Observatory of Heart Failure

Acute Heart Failure Clinical Trial

— ODIN  

Official title:

Permanent Observatory of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091441
• Other study ID #: 06302
• Status: Completed
• Start date: February 2007
• Est. completion date: July 2014

Study information

• Verified date: August 2019
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3248
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Locations

Country	Name	City	State
France	Brabois-Nancy University Hospital	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (5)

Agrinier N, Schockmel M, Thilly N, Laborde-Castérot H, Jourdain P, Alla F, Leclercq C, Dany F, Druelle J, Drouet E, Mulak G, Juillière Y; ODIN cohort participants. Effectiveness of a patient education programme in heart failure with preserved ejection fra — View Citation

Garbacz L, Juillière Y, Alla F, Jourdain P, Guyon G, Coudane H, Hervé C, Claudot F. Perception of therapeutic patient education in heart failure by healthcare providers. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):446-52. doi: 10.1016/j.acvd.2015.03.008. E — View Citation

Juillière Y, Jourdain P, Suty-Selton C, Béard T, Berder V, Maître B, Trochu JN, Drouet E, Pace B, Mulak G, Danchin N; ODIN Cohort Participants. Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity anal — View Citation

Juillière Y, Suty-Selton C, Riant E, Darracq JP, Dellinger A, Labarre JP, Druelle J, Mulak G, Danchin N, Jourdain P; ODIN cohort participants. Prescription of cardiovascular drugs in the French ODIN cohort of heart failure patients according to age and ty — View Citation

Schockmel M, Agrinier N, Jourdain P, Alla F, Eicher JC, Coulon P, Druelle J, Mulak G, Danchin N, Thilly N, Juillière Y; ODIN cohort participants. Socioeconomic factors and mortality in diastolic heart failure. Eur J Clin Invest. 2014 Apr;44(4):372-83. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	To analyse survival after 2 years of follow-up (all-causes death)	2 years
Secondary	Recurrence of heart failure	Analyze the data of disease: recurrence of heart failure	2 years
Secondary	Therapeutic	Analyze the data of disease: therapeutic took 2 years of follow-up	2 years
Secondary	Number of participants with adverse events	Analyze the data of disease: cardiovascular events or other non-cardiovascular	2 years