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

This study has been completed.

First Received: August 23, 2006 Last Updated: February 19, 2009 History of Changes

Sponsors and Collaborators:	Ottawa Health Research Institute The Kidney Foundation of Canada
Information provided by:	Ottawa Health 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:	Cohort, Prospective
Official Title:	Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Fistulas Kidney Failure

U.S. FDA Resources

Further study details as provided by Ottawa Health Research Institute:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	84
Study Start Date:	April 2002
Study Completion Date:	February 2007

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

lt;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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368147

Locations

Canada, Ontario
University Heatlh Network
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

Ottawa Health Research Institute

The Kidney Foundation of Canada

Investigators

Principal Investigator:

Deborah Zimmerman, MD

Ottawa Health Research Institute

More Information

No publications provided

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

Keywords provided by Ottawa Health Research Institute:

Hemodialysis
Arteriovenous Fistula
Arteriovenous Graft
Left Ventricular Hypertrophy
Brain Natriuretic Peptide

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 06, 2009