Epidemiology and Prognostic of the Acute Heart Failure

NCT02880358 | Unknown DMC

• 1 other identifier: 911069
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Acute Heart Failure

  Inclusion

Secondary Outcomes (1)

• Morbi-mortality of patients presenting an acute heart failure

  Inclusion, 6 month, 1, 2 and 3 years after acute heart failure

Other Outcomes (1)

• Effectiveness of therapeutic strategies on survival

  Inclusion, 6 months, 1, 2, and 3 years after acute heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital Center

Nancy, Lorraine, 54000, France

Location

Related Publications (1)

• 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.

  PMID: 30972619 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, serum, whole blood and urine

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Nathalie Thilly, PU-PH

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 26, 2016
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2017
• Last Updated: August 26, 2016

Record last verified: 2016-08

Locations

FR (1)