Renal Failure Clinical Trial
Official title:
Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation
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: 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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