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Access Creation for Hemodialysis: Association With Structural Changes of the Heart

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ClinicalTrials.gov Identifier: NCT00368147
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : February 20, 2009
Information provided by:

Study Description
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

Condition or disease
Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide

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

Study Design

Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling
Study Start Date : April 2002
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00368147

Canada, Ontario
University Heatlh Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Ottawa Hospital Research Institute
The Kidney Foundation of Canada
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
First Posted: August 24, 2006    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by Ottawa Hospital Research Institute:
Arteriovenous Fistula
Arteriovenous Graft
Left Ventricular Hypertrophy
Brain Natriuretic Peptide

Additional relevant MeSH terms:
Arteriovenous Fistula
Hypertrophy, Left Ventricular
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Heart Diseases