Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
Information source: Melbourne Health
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Failure; Left Ventricular Hypertrophy
Intervention: losartan (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Melbourne Health Official(s) and/or principal investigator(s):
Anuradha Aggarwal, Principal Investigator, Affiliation: Melbourne Health
Eugenia Pedagogos, FRACP,PhD, Principal Investigator, Affiliation: Melbourne Health
Overall contact:
Anuradha Aggarwal, FRACP,PhD, Email: anuradha.aggarwal@mh.org.au
Summary
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
Clinical Details
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: left ventricular hypertrophy
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30
mls/min).
2. Age >18 years of age and <85 years of age.
3. Males and post-menopausal, sterile women. Non-pregnant pre-menopausal women should be
on adequate contraception and have no intention of becoming pregnant during the
duration of the study.
4. At baseline TTE LVEF>45%
5. Willing and able to give informed consent.
Exclusion Criteria:
1. Serum potassium level of more than 5. 5 mmol/L
2. Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
3. Severe uncontrolled hypertension (diastolic BP >100mmHg or systolic BP >160 mmHg)
4. Evidence or suspicion of renovascular disease.
5. Atrial fibrillation
6. Evidence or suspicion of collagen disease, cancer, psychiatric disorder that
interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding
and ineffective contraception.
Locations and Contacts
Anuradha Aggarwal, FRACP,PhD, Email: anuradha.aggarwal@mh.org.au
Royal Melbourne Hospital, Parkville 3150, Australia; Recruiting
Anuradha Aggarwal, FrACP, PhD, Phone: 93427133, Email: anuradha.aggarwal@mh.org.au
Additional Information
Starting date: October 2006
Ending date: August 2008
Last updated: January 15, 2008
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