Overview

This trial is active, not recruiting.

Conditions decompensated chronic heart failure, heart failure nyha class iii, acute pulmonary edema, cardiogenic shock, heart failure nyha class iv
Sponsor Central Hospital, Nancy, France
Start date January 2011
End date December 2015
Trial size 2500 participants
Trial identifier NCT02880358, 911069

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Incidence of Acute Heart Failure
time frame: Inclusion

Secondary Outcomes

Measure
Morbi-mortality of patients presenting an acute heart failure
time frame: Inclusion, 6 month, 1, 2 and 3 years after acute heart failure

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France
Principal investigator Nathalie Thilly, PU-PH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Central Hospital, Nancy, France.