FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2

Heart Failure Clinical Trial

— OFICA2  

Official title:

FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05232058
• Other study ID #: 2019-A03222-55
• Status: Active, not recruiting
• Start date: March 22, 2021
• Est. completion date: March 2032

Study information

• Verified date: September 2022
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1593
• Est. completion date: March 2032
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
France	Hôpital Lariboisière, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyze survival during hospitalization	Rate of death during hospitalizaton	Trough length of hospitalization, an average of 10 days
Secondary	Analyze survival at 2 years after hospitalisation	Rate of death at 2 years	2 years after hospitalisation