NCT05232058

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,593

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 9, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

2.1 years

First QC Date

January 27, 2022

Last Update Submit

February 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analyze survival during hospitalization

    Rate of death during hospitalizaton

    Trough length of hospitalization, an average of 10 days

Secondary Outcomes (1)

  • Analyze survival at 2 years after hospitalisation

    2 years after hospitalisation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lariboisière, APHP

Paris, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 9, 2022

Study Start

March 22, 2021

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations