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

NCT ID: NCT00368147

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-04-30

Study Completion Date

2007-02-28

Brief Summary

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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

Detailed Description

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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

Conditions

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Arteriovenous Fistula Arteriovenous Graft Left Ventricular Hypertrophy Brain Natriuretic Peptide

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Kidney Foundation of Canada

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Kidney Research Centre

Principal Investigators

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Deborah Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

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University Heatlh Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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2002027-01H

Identifier Type: -

Identifier Source: org_study_id

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