Acute Heart FailureOFICANCT01080937
French Observatory of Acute Heart Failure
An observational study of Acute Heart Failure, run by French Cardiology Society at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 1,818 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Feb 2011
- 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: Hospitalized patient, whatever the mode of initial admission with acute heart failure (de novo heart failure or decompensation of chronic heart failure)
Who may be able to join
- Male or female age (e) over 18 years
- 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
- Patients who agreed to participate in the study
- Isolated right heart failure
Who cannot join
- expressed refusal to participate in the study
- Hospitalization scheduled for review
- Background surgery (immediate postoperative period)
- Diagnosis of acute heart failure reversed in favor of an alternative diagnosis before discharge from hospital
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Heart Failure
- Keywords
- acute heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with acute heart failure | Hospitalized patient, whatever the mode of initial admission with acute heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 3 months
Analyze survival 3 months after the end of initial hospitalization
Measured: 3 months
Secondary outcomes (7)
Hospital Methods
Compare methods of care based on clinical characteristics and hospital structures.
Measured: 3 months
Patterns of admission
Analyze patterns of admission and discharge of patients, depending on their characteristics
Measured: 3 months
Co-morbidities
Analyze the co-morbidities and their impact on care and survival
Measured: 3 months
Drug treatments
Analyze the evolution of drug treatment between the output and monitoring to 3 months
Measured: 3 months
Resources specific diagnostic
Analyze the use of resources specific diagnostic: measurement of BNP or NTproBNP, conducting echocardiogram, coronary angiography, Holter-ECG, Cardiac MRI, Cardiac CT
Measured: 3 months
Therapeutic resources
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
Measured: 3 months
During of stay
Analyze the duration of stay according to clinical characteristics.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 1,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien DL LOGEART, Principal investigator, French Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080937
- Sponsor's protocol ID
- SFC-OFICA
- Acronym
- OFICA
- Status last verified
- Sep 2023
- First submitted
- 1 Mar 2010
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.
PubMed 23186936Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.
PubMed 23697057Logeart 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observatory of Acute Heart Failure
- ClinicalTrials.gov ID
- NCT01080937
- Acronym / sponsor ID
- OFICA / SFC-OFICA
- Conditions
- Acute Heart Failure
- Keywords
- acute heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,818 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 5 Mar 2010 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with acute heart failure | – | –Hospitalized patient, whatever the mode of initial admission with acute heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patient, whatever the mode of initial admission with acute heart failure (de novo heart failure or decompensation of chronic heart failure)
Key inclusion criteria (8 listed)
- Male or female age (e) over 18 years
- 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):
- Patients who agreed to participate in the study
- Isolated right heart failure
Key exclusion criteria (4 listed)
- expressed refusal to participate in the study
- Hospitalization scheduled for review
- Background surgery (immediate postoperative period)
- Diagnosis of acute heart failure reversed in favor of an alternative diagnosis before discharge from hospital
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
Survival at 3 months
Time frame: 3 months
Analyze survival 3 months after the end of initial hospitalization
7 secondary outcomes
Hospital Methods
Time frame: 3 months
Patterns of admission
Time frame: 3 months
Co-morbidities
Time frame: 3 months
Drug treatments
Time frame: 3 months
Resources specific diagnostic
Time frame: 3 months
Therapeutic resources
Time frame: 3 months
During of stay
Time frame: 3 months
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 Sep 2023.
- Results publication: PubMed 23186936Logeart D, Isnard R, Resche-Rigon M, Seronde MF, de Groote P, Jondeau G, Galinier M, Mulak G, Donal E, Delahaye F, Juilliere Y, Damy T, Jourdain P, Bauer F, Eicher JC, Neuder Y, Trochu JN; Heart Failure of the French Society of Cardiology. Current aspects of the spectrum of acute heart failure syndromes in a real-life setting: the OFICA study. Eur J Heart Fail. 2013 Apr;15(4):465-76. doi: 10.1093/eurjhf/hfs189. Epub 2012 Nov 27.
- Results publication: PubMed 23697057Logeart D. [The OFICA study of acute heart failure]. Soins. 2013 Apr;(774):35. No abstract available. French.
- 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.
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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.
Damien DL LOGEART principal investigator
French Cardiology Society
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 Acute 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 8 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 Sep 2023. 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?
Survival at 3 months (time frame: 3 months). 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 NCT01080937, which also lists 3 linked publications.
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 Sep 2023.