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| Tracking Information | |||||
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| First Received Date ICMJE | August 23, 2006 | ||||
| Last Updated Date | February 19, 2009 | ||||
| Start Date ICMJE | April 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00368147 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Access Creation for Hemodialysis: Association With Structural Changes of the Heart | ||||
| Official Title ICMJE | Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling | ||||
| Brief Summary | The purpose of this study is to determine if the creation of a fistula or a graft plays a role in the development of heart disease for patients undergoing hemodialysis |
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| Detailed Description | Patients with end stage renal disease are at 18-20 times greater risk of dying from cardiovascular disease as the general population. Both traditional and non-traditional cardiovascular risk factors are thought to be important. Of the non-tradtional cardiovascular risk factors, creation of an arteriovenous fistula or graft for the purposes of a blood access for hemodialysis may contribute to an elevation in BNP and left ventricular hypertrophy - both factors that have been associated with an increased risk of mortality Prior to access creation and at one month and one year post access creation - samples for BNP will be collected Prior to access creation and at one year post access creation - echocardiography will be performed |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Prospective | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 84 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1)Hemodialysis 2)high risk for heart failure (DM, age>50, and/or systolic dysfunction) 3) first arteriovenous fistula/graft 4) informed consent 5) technically adequate echocardiogram 6) stable hgb(>100) 7) stable mineral metabolism (normal calcium, phosphate <2.1mmol/L, PTH>50pmol/L) Exclusion Criteria: 1)Expected survival <1 year 2) Expected to get a living donor transplant in one year 3)primary access failure 4) ARF |
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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 | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00368147 | ||||
| Responsible Party | Deborah Zimmerman, Kidney Research Centre | ||||
| Study ID Numbers ICMJE | 2002027-01H | ||||
| Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||
| Collaborators ICMJE | The Kidney Foundation of Canada | ||||
| Investigators ICMJE |
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| Information Provided By | Ottawa Hospital Research Institute | ||||
| Verification Date | February 2009 | ||||
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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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