Decompensated Chronic Heart FailureEPICAL2NCT02880358
Epidemiology and Prognostic of the Acute Heart Failure
An observational study of Decompensated Chronic Heart Failure and Heart Failure NYHA Class III, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Chronic Heart Failure, Heart Failure NYHA Class III, Acute Pulmonary Edema
- How many people
- 2,500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to May 2017
- 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: Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation. It is an exhaustive recruitment in a region of Northeast of France. So, there is no sampling
Who may be able to join
- Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
- Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France
EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.
Main objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :
Read more
- To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;
- To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;
- To evaluate the prognostic impact of the intra and extra-hospital care ;
- To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.
Secondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.
Read the detailed description
Criteria of inclusion:
- Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
- Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.
Acute heart failure includes decompensation of chronic heart failure, advanced stage of the heart failure, acute oedema of the lung and cardiogenic shock. According to the data of registers, the incidence of the acute heart failure in approximately 2,5 cases per 1000 adults per year, the expected sample size amounts to 2500 eligible patients over 1 year.
Data collection: the doctors declare the Acute Heart Failure of their departments. The technicians of clinical research collect the data concerning the sociodemographic, clinical, biological and therapeutic characteristics of the inclusive patients on arrival at the hospital, during the hospitalisation and at the exit. The biological takings are made for the patients having given their consent before the exit of the hospitalization. The patients are followed up during 3 years.
- Conditions
- Decompensated Chronic Heart Failure, Heart Failure NYHA Class III, Acute Pulmonary Edema, Cardiogenic Shock, Heart Failure NYHA Class IV
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Heart Failure
Measured: Inclusion
Secondary outcomes (1)
Morbi-mortality of patients presenting an acute heart failure
Measured: Inclusion, 6 month, 1, 2 and 3 years after acute heart failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionMay 2017 (estimated)
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 Decompensated Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Thilly, PU-PH, Principal investigator, ¹ INSERM, CIC-EC, CIE6, Nancy, F-54 000, France ² CHU Nancy, Epidémiologie et Evaluation Cliniques, Nancy, F-54 000, France ³ Université de Lorraine, CIC-EC, CIE 6, Nancy, F-54 000, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880358
- Sponsor's protocol ID
- 911069
- Acronym
- EPICAL2
- Status last verified
- Aug 2016
- First submitted
- 31 Jul 2013
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Al-Gobari M, Agrinier N, Soudant M, Burnand B, Thilly N. Effects of Statins to Reduce All-Cause Mortality in Heart Failure Patients: Findings from the EPICAL2 Cohort Study. Am J Cardiovasc Drugs. 2019 Oct;19(5):497-508. doi: 10.1007/s40256-019-00346-4.
PubMed 30972619
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France
- ClinicalTrials.gov ID
- NCT02880358
- Acronym / sponsor ID
- EPICAL2 / 911069
- Conditions
- Decompensated Chronic Heart Failure, Heart Failure NYHA Class III, Acute Pulmonary Edema, Cardiogenic Shock, Heart Failure NYHA Class IV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 26 Aug 2016 (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.
EPICAL 2 (Epidemiology and prognostic of the Acute Heart Failure) is an epidemiological, observational, prospective and multicenter study. This study includes at first an exhaustive recording of the cases on a geographic area at East of France, then the recorded patients are followed up in a cohort at least 3 years. This study follows the experiences of the EPICAL study led by our team.
Main objective: To describe the characteristics of the patients affected by acute heart failure and to identify prognostic factors, in particular related to care. More exactly :
- To describe the sociodemographic, clinical, biological and therapeutic characteristics of the patients presenting an acute heart failure during hospitalisation and living at East of France ;
- To study the short and medium-term morbi-mortality of these patients, and identify the main factors determining the prognosis for survival ;
- To evaluate the prognostic impact of the intra and extra-hospital care ;
- To identify the evolution of the care's practices of the decompensated heart failure since the EPICAL study (15 years) and their influence on the prognosis of the disease.
Secondary objective: to constitute a biological collection of serum, plasma and urine of patients' sample presenting an acute heart failure.
Detailed description
Criteria of inclusion:
- Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
- Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.
Acute heart failure includes decompensation of chronic heart failure, advanced stage of the heart failure, acute oedema of the lung and cardiogenic shock. According to the data of registers, the incidence of the acute heart failure in approximately 2,5 cases per 1000 adults per year, the expected sample size amounts to 2500 eligible patients over 1 year.
Data collection: the doctors declare the Acute Heart Failure of their departments. The technicians of clinical research collect the data concerning the sociodemographic, clinical, biological and therapeutic characteristics of the inclusive patients on arrival at the hospital, during the hospitalisation and at the exit. The biological takings are made for the patients having given their consent before the exit of the hospitalization. The patients are followed up during 3 years.
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
- Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation. It is an exhaustive recruitment in a region of Northeast of France. So, there is no sampling
Key inclusion criteria (2 listed)
- Patients hospitalized for acute heart failure or developing an acute heart failure during the hospitalisation in the intensive care, cardiology or geriatrics departments of the hospitals of Northeast of France during one year
- Patients died in emergencies or during the transfer, with a diagnosis of acute heart failure.
Key exclusion criteria (0 listed)
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
Incidence of Acute Heart Failure
Time frame: Inclusion
1 secondary outcome
Morbi-mortality of patients presenting an acute heart failure
Time frame: Inclusion, 6 month, 1, 2 and 3 years after acute heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Derived from this study: PubMed 30972619Al-Gobari M, Agrinier N, Soudant M, Burnand B, Thilly N. Effects of Statins to Reduce All-Cause Mortality in Heart Failure Patients: Findings from the EPICAL2 Cohort Study. Am J Cardiovasc Drugs. 2019 Oct;19(5):497-508. doi: 10.1007/s40256-019-00346-4.
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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.
Nathalie Thilly, PU-PH principal investigator
¹ INSERM, CIC-EC, CIE6, Nancy, F-54 000, France ² CHU Nancy, Epidémiologie et Evaluation Cliniques, Nancy, F-54 000, France ³ Université de Lorraine, CIC-EC, CIE 6, Nancy, F-54 000, France
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 Decompensated Chronic Heart Failure and Heart Failure NYHA Class III, run by Central Hospital, Nancy, France 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 0 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. 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?
Results are not available in the source record.
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?
Incidence of Acute Heart Failure (time frame: Inclusion). 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 NCT02880358, 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 26 Aug 2016.