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Sponsored by: |
Melbourne Health |
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Information provided by: | Melbourne Health |
ClinicalTrials.gov Identifier: | NCT00602004 |
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
Condition | Intervention |
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Renal Failure Left Ventricular Hypertrophy |
Drug: losartan |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 52 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | August 2008 |
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:
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anuradha Aggarwal, FRACP,PhD | anuradha.aggarwal@mh.org.au |
Australia | |
Royal Melbourne Hospital | Recruiting |
Parkville, Australia, 3150 | |
Contact: Anuradha Aggarwal, FrACP, PhD 93427133 anuradha.aggarwal@mh.org.au |
Principal Investigator: | Anuradha Aggarwal | Melbourne Health |
Principal Investigator: | Eugenia Pedagogos, FRACP,PhD | Melbourne Health |
Study ID Numbers: | 2006.059 |
Study First Received: | March 8, 2007 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00602004 |
Health Authority: | Australia: Human Research Ethics Committee |
Arteriovenous fistula hypertrophy losartan |
Pathological Conditions, Anatomical Hypertrophy, Left Ventricular Losartan Renal Insufficiency Heart Diseases Cardiovascular Abnormalities Arteriovenous Fistula Vascular Diseases Angiotensin II |
Fistula Hypertrophy Urologic Diseases Vascular Malformations Arteriovenous Malformations Kidney Diseases Congenital Abnormalities Cardiomegaly Kidney Failure |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Therapeutic Uses Vascular Fistula Cardiovascular Diseases |
Cardiovascular Agents Anti-Arrhythmia Agents Antihypertensive Agents Pharmacologic Actions |