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French Observatory of Acute Heart Failure (OFICA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080937
First Posted: March 5, 2010
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Logeart Damien, French Cardiology Society
  Purpose

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
Acute Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Observatory of Acute Heart Failure

Resource links provided by NLM:


Further study details as provided by Logeart Damien, French Cardiology Society:

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


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

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

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

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

  • 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

  • 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

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


Enrollment: 1818
Study Start Date: March 2009
Study Completion Date: February 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient with acute heart failure
Hospitalized patient, whatever the mode of initial admission with 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Logeart Damien, Professor, French Cardiology Society
ClinicalTrials.gov Identifier: NCT01080937     History of Changes
Other Study ID Numbers: SFC-OFICA
First Submitted: March 1, 2010
First Posted: March 5, 2010
Last Update Posted: June 14, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases