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NCT00368147 Clinical Trial

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

Arteriovenous Fistula Clinical Trial

Official title:
Access Creation for Hemodialysis: Potential Contribution to Left Ventricular Remodelling

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00368147
Other study ID # 2002027-01H
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2002
Est. completion date February 2007

Study information
Verified date November 2023
Source Ottawa Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada University Heatlh Network Toronto Ontario

Sponsors (2)
Lead Sponsor Collaborator
Ottawa Hospital Research Institute The Kidney Foundation of Canada

Country where clinical trial is conducted

Canada, 

See also
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Terminated NCT01321866 - Cutting Balloon Versus Non-cutting Balloon for the Treatment of Venous Stenosis in the Fistulas of Hemodialyzed Patients N/A