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French Observatory of Acute Heart Failure (OFICA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Logeart Damien, French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01080937
First received: March 1, 2010
Last updated: June 13, 2012
Last verified: June 2012
  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 French Cardiology Society:

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


Secondary Outcome Measures:
  • Hospital Methods [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare methods of care based on clinical characteristics and hospital structures.

  • Patterns of admission [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Analyze patterns of admission and discharge of patients, depending on their characteristics

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

  • Drug treatments [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Analyze the evolution of drug treatment between the output and monitoring to 3 months

  • Resources specific diagnostic [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by French Cardiology Society

Additional 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
Study First Received: March 1, 2010
Last Updated: June 13, 2012
Health Authority: France: National Commission on Informatics and Freedoms

Keywords provided by French Cardiology Society:
acute heart failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 24, 2014