Clinical trial NCT02880358: Epidemiology and Prognostic of the Acute Heart Failure
Official title: Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Decompensated Chronic Heart Failure
Heart Failure NYHA Class III
Acute Pulmonary Edema
Cardiogenic Shock
Heart Failure NYHA Class IV
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria :

* 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.

Primary outcomes:
measure: Incidence of Acute Heart Failure
timeFrame: Inclusion
Secondary outcomes:
measure: Morbi-mortality of patients presenting an acute heart failure
timeFrame: Inclusion, 6 month, 1, 2 and 3 years after acute heart failure
Other outcomes:
measure: Effectiveness of therapeutic strategies on survival
timeFrame: Inclusion, 6 months, 1, 2, and 3 years after acute heart failure
Locations:
city: Nancy
country: France
facility: University Hospital Center
state: Lorraine
Study officials:
affiliation: 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
name: Nathalie Thilly, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.