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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00568165
Other study ID # Code IDRCD : 2007- A00640 - 53
Secondary ID N°CPP : 0711602N
Status Completed
Phase N/A
First received December 4, 2007
Last updated October 25, 2010
Start date February 2008
Est. completion date July 2010

Study information

Verified date August 2010
Source University Paris 7 - Denis Diderot
Contact n/a
Is FDA regulated No
Health authority France: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection Authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. The hypothesis is that a mobile team will lead to shorter hospitalization.


Description:

Randomized, controlled, monocentric study comparing Standard care with the care provided by a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward on the duration of hospitalization, re-hospitalization rate à 30 days, emergency visit within 30 days, treatment at discharge, mortality within hospital stay and at 30 days.


Recruitment information / eligibility

Status Completed
Enrollment 504
Est. completion date July 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Hospitalized for suspected heart failure

- > or = 18 years

Exclusion Criteria:

- Refuses to participate

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
Mobile team
a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward
Standard care
Standard care

Locations

Country Name City State
France JONDEAU Paris

Sponsors (1)

Lead Sponsor Collaborator
University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of hospitalization. 30 days No
Secondary Re-hospitalization rate à 30 days Emergency visit within 30 days Treatment at discharge Mortality within hospital stay Mortality at 30 days 30 days No
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