Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
The primary objective is to determine if the use of losartan, an angiotensin II receptor blocker, can attenuate left ventricular hypertrophy, independent of its antihypertensive effects, in patients with near end stage chronic kidney disease (CKD) who have an arteriovenous fistula created.
Secondary outcomes include the impact of the medication on BNP and hyperkalaemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation|
- left ventricular hypertrophy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Study Completion Date:||December 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Study Design: This is a prospective double blind placebo control 2 arm, randomized (1:1) parallel group study in patients with near end stage renal failure who require creation of an arteriovenous fistula for future haemodialysis. Enrolment will be over a period of 12 months. The blinded phase will be for 3 months. The study design is summarized in Appendix 1. The study consists of a screening phase, a randomization phase and a treatment phase.
Patients will be randomized into 2 groups:
- Group 1 Losartan (50mg daily blinded) and 25 mg of atenolol
- Group 2 Placebo (blinded) and 25 mg of atenolol
Patients: Patients must comply with specified inclusion and exclusion criteria. The number of patients used will be sufficient to show a 15% difference in the left ventricular mass (LVM) between the two groups
Study Endpoints: The primary endpoint is the between group difference in LVM from baseline to 1 month.
Statistical Considerations: The analysis will be based upon an 'ANCOVA'-type linear regression model that includes baseline LVM and treatment group as explanatory variables, and final LVM as the outcome variable.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602004
|Royal Melbourne Hospital|
|Parkville, Australia, 3150|
|Principal Investigator:||Anuradha Aggarwal||Melbourne Health|
|Principal Investigator:||Eugenia Pedagogos, FRACP,PhD||Melbourne Health|