Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602004
• Other study ID #: 2006.059
• Status: Completed
• Phase: N/A
• First received: March 8, 2007
• Last updated: May 8, 2015
• Start date: October 2006
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• losartan
losartan 50 mg a day

Locations

Country	Name	City	State
Australia	Royal Melbourne Hospital	Parkville

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	left ventricular hypertrophy		3 months	No