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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00602004




Registration number
NCT00602004
Ethics application status
Date submitted
8/03/2007
Date registered
28/01/2008
Date last updated
12/05/2015

Titles & IDs
Public title
Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
Scientific title
Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation
Secondary ID [1] 0 0
2006.059
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Failure 0 0
Left Ventricular Hypertrophy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - losartan

Treatment: Drugs: losartan
losartan 50 mg a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
left ventricular hypertrophy
Timepoint [1] 0 0
3 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3150 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00602004
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anuradha Aggarwal
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00602004