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CompletedNCT00368147Updated Nov 13, 2023

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

An observational study in Arteriovenous Fistula, Arteriovenous Graft and Left Ventricular Hypertrophy, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Ottawa Hospital Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
84
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Arteriovenous Fistula
  • Arteriovenous Graft
  • Left Ventricular Hypertrophy
  • Brain Natriuretic Peptide

Keywords

  • Hemodialysis
  • Arteriovenous Fistula
  • Arteriovenous Graft
  • Left Ventricular Hypertrophy
  • Brain Natriuretic Peptide
03

In context

Arteriovenous Fistula

247 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

This study's enrollment of 84 is below the median of 100 across 70 observational studies indexed under Arteriovenous Fistula.

Browse Arteriovenous Fistula studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 547 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: 1)Hemodialysis 2)high risk for heart failure (DM, age>50, and/or systolic dysfunction) 3) first arteriovenous fistula/graft 4) 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
84 participants (actual)
06

Study locations

1 site
  • University Heatlh Network
    Toronto, Ontario M5G 2C4, Canada
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00368147
Collaborators
The Kidney Foundation of Canada
First posted
Aug 24, 2006
Start date
Apr 2002
Completion
Feb 2007
Last update
Nov 13, 2023

Study contacts

Deborah Zimmerman, MD
principal investigator · Ottawa Hospital Research Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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