Gulf Acute Heart Failure Registry (GulfCARE)
| Tracking Information | |||||
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| First Received Date ICMJE | November 7, 2011 | ||||
| Last Updated Date | January 9, 2013 | ||||
| Start Date ICMJE | February 2012 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Study of acute heart failure in the Middle-East [ Time Frame: One year ] [ Designated as safety issue: No ] To describe the epidemiology, etiology, precipitating factors, demographics, clinical characteristics, management and outcome of patients admitted with acute heart failure in the Middle-East. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01467973 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To identify targets for the long term objectives of improving quality of care in acute heart failure patients from the Middle-East [ Time Frame: One year ] [ Designated as safety issue: No ] 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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gulf Acute Heart Failure Registry | ||||
| Official Title ICMJE | Gulf aCute heArt failuRe rEgistry (Gulf CARE) | ||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients admitted to various hospitals in the Middle-East with acute heart failure. |
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| Condition ICMJE | Acute Heart Failure | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 5140 | ||||
| Estimated Completion Date | November 2013 | ||||
| Primary Completion Date | November 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Oman | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01467973 | ||||
| Other Study ID Numbers ICMJE | GHA4 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Gulf Heart Association | ||||
| Study Sponsor ICMJE | Gulf Heart Association | ||||
| Collaborators ICMJE | Servier | ||||
| Investigators ICMJE |
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| Information Provided By | Gulf Heart Association | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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