NCT01091441

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

7.4 years

First QC Date

March 18, 2010

Last Update Submit

August 6, 2019

Conditions

Acute Heart Failure

Keywords

therapeutic education

Outcome Measures

Primary Outcomes (1)

  • Event-free survival

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

    2 years

Secondary Outcomes (3)

  • Recurrence of heart failure

    2 years

  • Therapeutic

    2 years

  • Number of participants with adverse events

    2 years

Study Arms (1)

Patients with heart failure

Patients hospitalized for acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Patient with heart failure
  • Patient supported by a center participating in the I-CARE french program

You may not qualify if:

  • Refusal by the patient to be listed in an observatory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brabois-Nancy University Hospital

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (5)

  • Schockmel M, Agrinier N, Jourdain P, Alla F, Eicher JC, Coulon P, Druelle J, Mulak G, Danchin N, Thilly N, Juilliere Y; ODIN cohort participants. Socioeconomic factors and mortality in diastolic heart failure. Eur J Clin Invest. 2014 Apr;44(4):372-83. doi: 10.1111/eci.12246. Epub 2014 Feb 19.

    PMID: 24467732RESULT

  • Juilliere 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 type of chronic heart failure. Arch Cardiovasc Dis. 2014 Jan;107(1):21-32. doi: 10.1016/j.acvd.2013.11.001. Epub 2013 Dec 30.

    PMID: 24388162RESULT

  • Juilliere Y, Jourdain P, Suty-Selton C, Beard T, Berder V, Maitre 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 analysis. Int J Cardiol. 2013 Sep 20;168(1):388-95. doi: 10.1016/j.ijcard.2012.09.030. Epub 2012 Oct 6.

    PMID: 23046596RESULT

  • Agrinier N, Schockmel M, Thilly N, Laborde-Casterot H, Jourdain P, Alla F, Leclercq C, Dany F, Druelle J, Drouet E, Mulak G, Juilliere Y; ODIN cohort participants. Effectiveness of a patient education programme in heart failure with preserved ejection fraction: Results from the ODIN cohort study using propensity score matching. Arch Cardiovasc Dis. 2018 Jan;111(1):5-16. doi: 10.1016/j.acvd.2017.03.010. Epub 2017 Sep 22.

    PMID: 28943262RESULT

  • Garbacz L, Juilliere Y, Alla F, Jourdain P, Guyon G, Coudane H, Herve 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. Epub 2015 Jun 10.

    PMID: 26071349RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 24, 2010

Study Start

February 1, 2007

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

FR(1)