French Observatory of Acute Heart Failure

Acute Heart Failure Clinical Trial

— OFICA  

Official title:

French Observatory of Acute Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080937
• Other study ID #: SFC-OFICA
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

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