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| Sponsor: | Ottawa Hospital Research Institute |
|---|---|
| Collaborator: |
The Kidney Foundation of Canada |
| Information provided by: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT00368147 |
Purpose
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 |
|---|
|
Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: 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
Eligibility| 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
Contacts and Locations| Canada, Ontario | |
| University Heatlh Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Principal Investigator: | Deborah Zimmerman, MD | Ottawa Hospital Research Institute |
More Information
| Responsible Party: | Deborah Zimmerman, Kidney Research Centre |
| ClinicalTrials.gov Identifier: | NCT00368147 History of Changes |
| Other Study ID Numbers: | 2002027-01H |
| Study First Received: | August 23, 2006 |
| Last Updated: | February 19, 2009 |
| Health Authority: | Canada: Health Canada |
|
Hemodialysis Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide |
|
Arteriovenous Fistula Fistula Hypertrophy Hypertrophy, Left Ventricular Ventricular Remodeling Arteriovenous Malformations Vascular Malformations Cardiovascular Abnormalities Cardiovascular Diseases Vascular Fistula Vascular Diseases |
Congenital Abnormalities Pathological Conditions, Anatomical Cardiomegaly Heart Diseases Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
