Permanent Observatory of Heart Failure | NCT01091441

Studies
Permanent Observatory of Heart Failure

NCT01091441

Sponsor

French Cardiology Society

Status

Completed

Last Update Posted

Aug 7, 2019Actual

Enrollment

3,248Actual

Phase

Not provided

Conditions

Acute Heart Failure

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Mar 18, 2010

First Submission Date that Met QC Criteria

Mar 23, 2010

First Posted Date

Mar 24, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2019

Last Update Posted Date

Aug 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,248Actual

Label	Type	Description	Intervention Names
Patients with heart failure		Patients hospitalized for acute heart failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Event-free survival	To analyse survival after 2 years of follow-up (all-causes death)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Recurrence of heart failure	Analyze the data of disease: recurrence of heart failure	2 years
Therapeutic	Analyze the data of disease: therapeutic took 2 years of follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brabois-Nancy University Hospital		Vandœuvre-lès-Nancy		54500	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24467732	Result	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.
24388162	Result