Epidemiology and Prognostic of the Acute Heart Failure

• Conditions: Decompensated Chronic Heart Failure; Cardiogenic Shock; Heart Failure NYHA Class IV; Heart Failure NYHA Class III; Acute Pulmonary Edema

• Registration Number: NCT02880358
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-07-31
• Primary Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Heart Failure	Inclusion

Secondary Outcome Measures

Name	Time	Method
Morbi-mortality of patients presenting an acute heart failure	Inclusion, 6 month, 1, 2 and 3 years after acute heart failure

Trial Locations

Locations (1)

University Hospital Center; 🇫🇷 Nancy, Lorraine, France