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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01080937
Other study ID # SFC-OFICA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2009
Est. completion date February 2011

Study information

Verified date September 2023
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

During the last decade, progress has been made in the management of heart failure. However, the changing characteristics of patients and practices in the "real world" and their impact on the prognosis of patients admitted for acute heart failure remain poorly studied. 2000 consecutive patients recruited in a single day in hospitals volunteered to participate in the cohort during a day dedicated.


Description:

The total duration of recruitment is one day (date to be set soon by the Executive Committee): all patients hospitalized, and whatever their date of admission with the diagnosis of heart failure will be selected for the study. Information on each hospital stay will be obtained at baseline and at the end of the hospitalization by the hospital teams. A telephone follow-up will be conducted at 3 months among survivors and / or their doctor by CRAs dedicated to the French Society of Cardiology.


Recruitment information / eligibility

Status Completed
Enrollment 1818
Est. completion date February 2011
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female age (e) over 18 years 2. Inpatient, whatever the mode of initial admission with acute heart failure (de novo heart failure or decompensation of chronic heart failure) regardless of severity, corresponding to one of the following clinical situations (clinical criteria in Appendix 1): - Pulmonary edema, hypertensive or not - congestive heart failure (pulmonary congestion and peripheral edema) - cardiogenic shock - Insufficient high output cardiac 3. Patients who agreed to participate in the study 4. Isolated right heart failure Exclusion Criteria: 1. expressed refusal to participate in the study 2. Hospitalization scheduled for review 3. Background surgery (immediate postoperative period) 4. Diagnosis of acute heart failure reversed in favor of an alternative diagnosis before discharge from hospital

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Lariboisiere Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (2)

Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects — View Citation

Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival at 3 months Analyze survival 3 months after the end of initial hospitalization 3 months
Secondary Hospital Methods Compare methods of care based on clinical characteristics and hospital structures. 3 months
Secondary Patterns of admission Analyze patterns of admission and discharge of patients, depending on their characteristics 3 months
Secondary Co-morbidities Analyze the co-morbidities and their impact on care and survival 3 months
Secondary Drug treatments Analyze the evolution of drug treatment between the output and monitoring to 3 months 3 months
Secondary Resources specific diagnostic Analyze the use of resources specific diagnostic: measurement of BNP or NTproBNP, conducting echocardiogram, coronary angiography, Holter-ECG, Cardiac MRI, Cardiac CT 3 months
Secondary Therapeutic resources Analyze the use of therapeutic resources based on specific clinical features: intensive care, ventilation, inotropes, ultrafiltration, introduction of beta-blockers, stimulation, implantable cardioverter defibrillator, circulatory support, graft 3 months
Secondary During of stay Analyze the duration of stay according to clinical characteristics. 3 months
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