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Sponsors and Collaborators: |
Ottawa Hospital Research Institute The Kidney Foundation of Canada |
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Information provided by: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT00368147 |
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
Condition |
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Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling |
Enrollment: | 84 |
Study Start Date: | April 2002 |
Study Completion Date: | February 2007 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Canada, Ontario | |
University Heatlh Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Deborah Zimmerman, MD | Ottawa Hospital Research Institute |
Responsible Party: | Kidney Research Centre ( Deborah Zimmerman ) |
Study ID Numbers: | 2002027-01H |
Study First Received: | August 23, 2006 |
Last Updated: | February 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00368147 History of Changes |
Health Authority: | Canada: Health Canada |
Hemodialysis Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide |
Pathological Conditions, Anatomical Natriuretic Peptide, Brain Hypertrophy, Left Ventricular Heart Diseases Cardiovascular Abnormalities Arteriovenous Fistula Vascular Diseases |
Fistula Hypertrophy Vascular Malformations Arteriovenous Malformations Congenital Abnormalities Cardiomegaly |
Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Heart Diseases Cardiovascular Abnormalities Arteriovenous Fistula Vascular Fistula Vascular Diseases |
Fistula Hypertrophy Vascular Malformations Arteriovenous Malformations Cardiovascular Diseases Congenital Abnormalities Cardiomegaly |