Epidemiology and Prognostic of the Acute Heart Failure

Cardiogenic Shock Clinical Trial

— EPICAL2  

Official title:

Epidemiology and Prognostic of the Acute Heart Failure in Northeast of France

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02880358
• Other study ID #: 911069
• Status: Active, not recruiting
• Phase: N/A
• First received: July 31, 2013
• Last updated: August 23, 2016
• Start date: January 2011
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: May 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pulmonary Edema
• Cardiogenic Shock
• Decompensated Chronic Heart Failure
• Heart Failure
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV
• Pulmonary Edema
• Shock, Cardiogenic

Locations

Country	Name	City	State
France	University Hospital Center	Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effectiveness of therapeutic strategies on survival	Patient medical record data (treatment, support network, therapeutic education)	Inclusion, 6 months, 1, 2, and 3 years after acute heart failure	No
Primary	Incidence of Acute Heart Failure		Inclusion	No
Secondary	Morbi-mortality of patients presenting an acute heart failure		Inclusion, 6 month, 1, 2 and 3 years after acute heart failure	No