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French Observatory of Acute Heart Failure (OFICA)

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ClinicalTrials.gov Identifier: NCT01080937
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Logeart Damien, French Cardiology Society

Brief 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.


Condition or disease
Acute Heart Failure

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 : Observational
Actual Enrollment : 1818 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Observatory of Acute Heart Failure
Study Start Date : March 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort
Patient with acute heart failure
Hospitalized patient, whatever the mode of initial admission with acute heart failure



Primary Outcome Measures :
  1. Survival at 3 months [ Time Frame: 3 months ]
    Analyze survival 3 months after the end of initial hospitalization


Secondary Outcome Measures :
  1. Hospital Methods [ Time Frame: 3 months ]
    Compare methods of care based on clinical characteristics and hospital structures.

  2. Patterns of admission [ Time Frame: 3 months ]
    Analyze patterns of admission and discharge of patients, depending on their characteristics

  3. Co-morbidities [ Time Frame: 3 months ]
    Analyze the co-morbidities and their impact on care and survival

  4. Drug treatments [ Time Frame: 3 months ]
    Analyze the evolution of drug treatment between the output and monitoring to 3 months

  5. Resources specific diagnostic [ Time Frame: 3 months ]
    Analyze the use of resources specific diagnostic: measurement of BNP or NTproBNP, conducting echocardiogram, coronary angiography, Holter-ECG, Cardiac MRI, Cardiac CT

  6. Therapeutic resources [ Time Frame: 3 months ]
    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

  7. During of stay [ Time Frame: 3 months ]
    Analyze the duration of stay according to clinical characteristics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patient, whatever the mode of initial admission with acute heart failure (de novo heart failure or decompensation of chronic heart failure)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080937


Locations
France
Lariboisiere Hospital
Paris, France, 75010
Sponsors and Collaborators
French Cardiology Society
Investigators
Principal Investigator: Damien DL LOGEART French Cardiology Society

Publications of Results:
Responsible Party: Logeart Damien, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01080937     History of Changes
Other Study ID Numbers: SFC-OFICA
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Logeart Damien, French Cardiology Society:
acute heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases