Heart FailureOFICA2NCT05232058
FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2
An observational study of Heart Failure, run by French Cardiology Society at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,593 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2021to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze survival during hospitalization
Rate of death during hospitalizaton
Measured: Trough length of hospitalization, an average of 10 days
Secondary outcomes (1)
Analyze survival at 2 years after hospitalisation
Rate of death at 2 years
Measured: 2 years after hospitalisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start22 Mar 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,593 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232058
- Sponsor's protocol ID
- 2019-A03222-55
- Acronym
- OFICA2
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Logeart D, Alos B, Legalloisl D, Guillaume C, Costa J, Puymirat E, Turlotte G, Thuaire C, Picard F, Jondeau G, Trochu JN, Donal E, De Groote P, Bodez D, Delmas C, Salvat M, Legrand L, Doublet M, Bouleti C. Temporal trends in characteristics, management and prognosis of patients with acute heart failure through two repeated snapshots. Heart. 2026 May 13:heartjnl-2025-327454. doi: 10.1136/heartjnl-2025-327454. Online ahead of print.
PubMed 42128625
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2
- ClinicalTrials.gov ID
- NCT05232058
- Acronym / sponsor ID
- OFICA2 / 2019-A03222-55
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,593 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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 :
- Patient who agreed to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analyze survival during hospitalization
Time frame: Trough length of hospitalization, an average of 10 days
Rate of death during hospitalizaton
1 secondary outcome
Analyze survival at 2 years after hospitalisation
Time frame: 2 years after hospitalisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 42128625Logeart D, Alos B, Legalloisl D, Guillaume C, Costa J, Puymirat E, Turlotte G, Thuaire C, Picard F, Jondeau G, Trochu JN, Donal E, De Groote P, Bodez D, Delmas C, Salvat M, Legrand L, Doublet M, Bouleti C. Temporal trends in characteristics, management and prognosis of patients with acute heart failure through two repeated snapshots. Heart. 2026 May 13:heartjnl-2025-327454. doi: 10.1136/heartjnl-2025-327454. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by French Cardiology Society at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze survival during hospitalization (time frame: Trough length of hospitalization, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.