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

This study has been completed.
Sponsor:
Collaborator:
The Kidney Foundation of Canada
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00368147
First received: August 23, 2006
Last updated: February 19, 2009
Last verified: February 2009
  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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

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 <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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Hospital Research Institute
The Kidney Foundation of Canada
Investigators
Principal Investigator: Deborah Zimmerman, MD Ottawa Hospital Research Institute
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on October 20, 2014