FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2 (OFICA2)

In 2009, OFICA 1 provided a snapshot of the management of acute heart failure in France.

Over the past 10 years, practitioners have observed a change in the profiles of hospitalized patients and it is necessary to specify the evolution of these characteristics, especially since the recommendations concerning management have changed significantly; this is the objective of this observatory.

Like patients suffering from chronic diseases such as diabetes or asthma, heart failure patients are therefore at the center of their management. Compliance is improved when patients have understood the reason for the prescription. Ideally, compliance should not be achieved by respecting externally imposed norms, but rather by respecting norms that are understood, adapted, personalized and accepted.

A self-questionnaire will thus be given to patients on the day of inclusion in the study.

In heart failure patients with an average age of 80 years, systematic screening for cognitive disorders using a simple test recommended by the French National Authority for Health (Haute Autorité de Santé), the codex test, will make it possible to offer more appropriate care if necessary (geriatric or neurology consultation).

Finally, follow-up at 3 months and at 1 and 2 years will be carried out by matching with data from the National Health Data System (SNDS)

Study Overview

• Status: Completed
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Actual): 1593

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital Lariboisière, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Only inpatient facilities with at least one cardiology unit will be selected. The inclusion services will be restricted within these institutions to cardiology services, intensive care units, door beds, and internal medicine and geriatric servicesThe diagnosis of acute heart failure will be made by the investigating physician in each center, according to the clinical and paraclinical elements at his disposal.

Description

Inclusion Criteria:

• Patient hospitalized, regardless of the initial mode of admission, with acute heart failure (de novo heart failure or decompensation of chronic heart failure) of any severity and corresponding to one of the following clinical situations :

  1. Pulmonary edema, hypertensive or not
  2. Congestive heart failure (pulmonary congestion, peripheral oedema)
  3. Cardiogenic shock
  4. High output heart failure
  5. Isolated right heart failure
• Patient who agreed to participate in the study

Exclusion Criteria:

• Expressed refusal to participate in the study
• Scheduled hospitalization for assessment
• Surgical context (immediate postoperative period)
• Diagnosis of acute heart failure reversed to another diagnosis before end of hospitalization

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze survival during hospitalization	Rate of death during hospitalizaton	Trough length of hospitalization, an average of 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze survival at 2 years after hospitalisation	Rate of death at 2 years	2 years after hospitalisation

Collaborators and Investigators

• Sponsor: French Cardiology Society

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2019-A03222-55

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No