Gulf Acute Heart Failure Registry

Acute Heart Failure Clinical Trial

— GulfCARE  

Official title:

Gulf aCute heArt failuRe rEgistry (Gulf CARE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467973
• Other study ID #: GHA4
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: April 20, 2014
• Start date: February 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Gulf Heart Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: Qatar: Hamad Medical Corporation
• Study type: Observational

Clinical Trial Summary

The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up.

Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region.

Description:

The Gulf Heart Association (GHA) initiated Gulf acute heart failure registry (Gulf CARE)is designed to assess epidemiology, clinical data, management and outcomes of AHF in six Gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. The registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The information gathered will identify management gaps in diagnosis and care of AHF patients that may be addressed by more effective implementation of current guidelines or development of AHF guidelines which may be appropriate to this region. Findings from this registry may help in knowing the current status of heart transplantation in the Middle-East countries as well as identify issues in establishing future heart transplant programme including selection of appropriate candidates and donors, requirements for pre- and post-transplant support.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5005
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of acute heart failure

• Admitted to the participating hospitals

Exclusion Criteria:

• Patients with acute heart failure who are discharged from the emergency room without admission.

• Patients transferred from non-registry hospital

• Failure to obtain informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Oman	Royal Hospital	Muscat

Sponsors (2)

Lead Sponsor	Collaborator
Gulf Heart Association	Servier

Country where clinical trial is conducted

Oman, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of acute heart failure in the Middle-East	To describe the epidemiology, etiology, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted with acute heart failure in the Middle-East.	One year	No
Secondary	To identify targets for the long term objectives of improving quality of care in acute heart failure patients from the Middle-East	To identify targets for the long term objectives of improving quality of care, reducing morbidity and mortality and lowering the cost of managing patients with acute heart failure in the Middle-East	One year	No