Acute Heart FailureODINNCT01091441
Permanent Observatory of Heart Failure
An observational study of Acute Heart Failure, run by French Cardiology Society at 1 site in France.
Trial summary
The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. 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
- 3,248 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2007to Jul 2014
- 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: All patients with heart failure in France The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology (The Task Force for the Diagnosis and Treatment of Congestive Heart Failure of the European Society of Cardiology. Eur Heart J 2005; 26: 1115 -- 1140): presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure
Who may be able to join
- Patient with heart failure
- Patient supported by a center participating in the I-CARE french program
Who cannot join
- Refusal by the patient to be listed in an observatory
Trial locations and contacts
1 site in 1 country.
About this study
The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated. Patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
The following of patients will be periodic after their entry in the observatory, up to 2 years of follow up.
Read the detailed description
The Center for patients with heart failure cared for in a center practicing therapeutic education dedicated to heart failure.
The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology : presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure.
All patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated.
All patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
Follow up is done by CRAs at the French Society of Cardiology, by mailing and phone contacts.
- Conditions
- Acute Heart Failure
- Keywords
- therapeutic education
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 |
|---|---|---|
| Patients with heart failure | Patients hospitalized for acute heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
To analyse survival after 2 years of follow-up (all-causes death)
Measured: 2 years
Secondary outcomes (3)
Recurrence of heart failure
Analyze the data of disease: recurrence of heart failure
Measured: 2 years
Therapeutic
Analyze the data of disease: therapeutic took 2 years of follow-up
Measured: 2 years
Number of participants with adverse events
Analyze the data of disease: cardiovascular events or other non-cardiovascular
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startFeb 2007
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 3,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juilliere, French Cardiology Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091441
- Sponsor's protocol ID
- 06302
- Acronym
- ODIN
- Status last verified
- Aug 2019
- First submitted
- 18 Mar 2010
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schockmel M, Agrinier N, Jourdain P, Alla F, Eicher JC, Coulon P, Druelle J, Mulak G, Danchin N, Thilly N, Juilliere Y; ODIN cohort participants. Socioeconomic factors and mortality in diastolic heart failure. Eur J Clin Invest. 2014 Apr;44(4):372-83. doi: 10.1111/eci.12246. Epub 2014 Feb 19.
PubMed 24467732Juilliere Y, Suty-Selton C, Riant E, Darracq JP, Dellinger A, Labarre JP, Druelle J, Mulak G, Danchin N, Jourdain P; ODIN cohort participants. Prescription of cardiovascular drugs in the French ODIN cohort of heart failure patients according to age and type of chronic heart failure. Arch Cardiovasc Dis. 2014 Jan;107(1):21-32. doi: 10.1016/j.acvd.2013.11.001. Epub 2013 Dec 30.
PubMed 24388162Juilliere Y, Jourdain P, Suty-Selton C, Beard T, Berder V, Maitre B, Trochu JN, Drouet E, Pace B, Mulak G, Danchin N; ODIN Cohort Participants. Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity analysis. Int J Cardiol. 2013 Sep 20;168(1):388-95. doi: 10.1016/j.ijcard.2012.09.030. Epub 2012 Oct 6.
PubMed 23046596Agrinier N, Schockmel M, Thilly N, Laborde-Casterot H, Jourdain P, Alla F, Leclercq C, Dany F, Druelle J, Drouet E, Mulak G, Juilliere Y; ODIN cohort participants. Effectiveness of a patient education programme in heart failure with preserved ejection fraction: Results from the ODIN cohort study using propensity score matching. Arch Cardiovasc Dis. 2018 Jan;111(1):5-16. doi: 10.1016/j.acvd.2017.03.010. Epub 2017 Sep 22.
PubMed 28943262Garbacz L, Juilliere Y, Alla F, Jourdain P, Guyon G, Coudane H, Herve C, Claudot F. Perception of therapeutic patient education in heart failure by healthcare providers. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):446-52. doi: 10.1016/j.acvd.2015.03.008. Epub 2015 Jun 10.
PubMed 26071349
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Observatory of Heart Failure
- ClinicalTrials.gov ID
- NCT01091441
- Acronym / sponsor ID
- ODIN / 06302
- Conditions
- Acute Heart Failure
- Keywords
- therapeutic education
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,248 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 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.
The observatory consists of a row of data collection on a population composed of all patients with heart failure cared for in centers participating in the national education program for patients (named I-CARE) in the form of two groups. Patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated. Patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
The following of patients will be periodic after their entry in the observatory, up to 2 years of follow up.
Detailed description
The Center for patients with heart failure cared for in a center practicing therapeutic education dedicated to heart failure.
The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology : presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure.
All patients who are undergoing a program of therapeutic education track are listed and included in the group of patients educated.
All patients who receive no education or only a minimal element for any reason whatsoever are also listed and included in the group of patients who are not educated.
Follow up is done by CRAs at the French Society of Cardiology, by mailing and phone contacts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure | – | –Patients hospitalized for acute heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with heart failure in France The definition of heart failure selected for inclusion is that recommended by the European Society of Cardiology (The Task Force for the Diagnosis and Treatment of Congestive Heart Failure of the European Society of Cardiology. Eur Heart J 2005; 26: 1115 -- 1140): presence of at least two signs or symptoms of heart failure (dyspnea, edema of the ankles crackles) at rest or during exercise associated with objective evidence (preferably by echocardiography) of cardiac dysfunction ( systolic and / or diastolic) (resting) and in case of doubt, a response to specific treatment of heart failure
Key inclusion criteria (2 listed)
- Patient with heart failure
- Patient supported by a center participating in the I-CARE french program
Key exclusion criteria (1 listed)
- Refusal by the patient to be listed in an observatory
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
Event-free survival
Time frame: 2 years
To analyse survival after 2 years of follow-up (all-causes death)
3 secondary outcomes
Recurrence of heart failure
Time frame: 2 years
Therapeutic
Time frame: 2 years
Number of participants with adverse events
Time frame: 2 years
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 7 Aug 2019.
- Results publication: PubMed 24467732Schockmel M, Agrinier N, Jourdain P, Alla F, Eicher JC, Coulon P, Druelle J, Mulak G, Danchin N, Thilly N, Juilliere Y; ODIN cohort participants. Socioeconomic factors and mortality in diastolic heart failure. Eur J Clin Invest. 2014 Apr;44(4):372-83. doi: 10.1111/eci.12246. Epub 2014 Feb 19.
- Results publication: PubMed 24388162Juilliere Y, Suty-Selton C, Riant E, Darracq JP, Dellinger A, Labarre JP, Druelle J, Mulak G, Danchin N, Jourdain P; ODIN cohort participants. Prescription of cardiovascular drugs in the French ODIN cohort of heart failure patients according to age and type of chronic heart failure. Arch Cardiovasc Dis. 2014 Jan;107(1):21-32. doi: 10.1016/j.acvd.2013.11.001. Epub 2013 Dec 30.
- Results publication: PubMed 23046596Juilliere Y, Jourdain P, Suty-Selton C, Beard T, Berder V, Maitre B, Trochu JN, Drouet E, Pace B, Mulak G, Danchin N; ODIN Cohort Participants. Therapeutic patient education and all-cause mortality in patients with chronic heart failure: a propensity analysis. Int J Cardiol. 2013 Sep 20;168(1):388-95. doi: 10.1016/j.ijcard.2012.09.030. Epub 2012 Oct 6.
- Results publication: PubMed 28943262Agrinier N, Schockmel M, Thilly N, Laborde-Casterot H, Jourdain P, Alla F, Leclercq C, Dany F, Druelle J, Drouet E, Mulak G, Juilliere Y; ODIN cohort participants. Effectiveness of a patient education programme in heart failure with preserved ejection fraction: Results from the ODIN cohort study using propensity score matching. Arch Cardiovasc Dis. 2018 Jan;111(1):5-16. doi: 10.1016/j.acvd.2017.03.010. Epub 2017 Sep 22.
- Results publication: PubMed 26071349Garbacz L, Juilliere Y, Alla F, Jourdain P, Guyon G, Coudane H, Herve C, Claudot F. Perception of therapeutic patient education in heart failure by healthcare providers. Arch Cardiovasc Dis. 2015 Aug-Sep;108(8-9):446-52. doi: 10.1016/j.acvd.2015.03.008. Epub 2015 Jun 10.
Related trials for Acute Heart Failure
Not yet recruiting
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF)
Acute Heart Failure (AHF)
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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 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 2 inclusion and 1 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 7 Aug 2019. 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?
Event-free survival (time frame: 2 years). 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 NCT01091441, which also lists 5 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 7 Aug 2019.