- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01080937
French Observatory of Acute Heart Failure (OFICA)
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75010
- Lariboisiere Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female age (e) over 18 years
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
- Patients who agreed to participate in the study
- Isolated right heart failure
Exclusion Criteria:
- expressed refusal to participate in the study
- Hospitalization scheduled for review
- Background surgery (immediate postoperative period)
- Diagnosis of acute heart failure reversed in favor of an alternative diagnosis before discharge from hospital
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient with acute heart failure
Hospitalized patient, whatever the mode of initial admission with acute heart failure
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Survival at 3 months
Time Frame: 3 months
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Analyze survival 3 months after the end of initial hospitalization
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hospital Methods
Time Frame: 3 months
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Compare methods of care based on clinical characteristics and hospital structures.
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3 months
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Patterns of admission
Time Frame: 3 months
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Analyze patterns of admission and discharge of patients, depending on their characteristics
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3 months
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Co-morbidities
Time Frame: 3 months
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Analyze the co-morbidities and their impact on care and survival
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3 months
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Drug treatments
Time Frame: 3 months
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Analyze the evolution of drug treatment between the output and monitoring to 3 months
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3 months
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Resources specific diagnostic
Time Frame: 3 months
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Analyze the use of resources specific diagnostic: measurement of BNP or NTproBNP, conducting echocardiogram, coronary angiography, Holter-ECG, Cardiac MRI, Cardiac CT
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3 months
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Therapeutic resources
Time Frame: 3 months
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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
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3 months
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During of stay
Time Frame: 3 months
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Analyze the duration of stay according to clinical characteristics.
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Damien DL LOGEART, French Cardiology Society
Publications and helpful links
General Publications
- 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 of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.
- Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SFC-OFICA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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