Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan
Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation
1 other identifier
interventional
52
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 8, 2007
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMay 12, 2015
May 1, 2015
7.8 years
March 8, 2007
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
left ventricular hypertrophy
3 months
Interventions
losartan 50 mg a day
Eligibility Criteria
You may qualify if:
- Diagnosis of CKD at near-end stage renal failure (CKD Stage IV) ( eGFR = 15-30 mls/min).
- Age \>18 years of age and \<85 years of age.
- 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.
- At baseline TTE LVEF\>45%
- Willing and able to give informed consent.
You may not qualify if:
- Serum potassium level of more than 5.5 mmol/L
- Acute myocardial infarction or cerebrovascular accident in the previous 6 months.
- Severe uncontrolled hypertension (diastolic BP \>100mmHg or systolic BP \>160 mmHg)
- Evidence or suspicion of renovascular disease.
- Atrial fibrillation
- Evidence or suspicion of collagen disease, cancer, psychiatric disorder that interferes with patient compliance, drug or alcohol abuse, pregnancy, breast feeding and ineffective contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
Study Sites (1)
Royal Melbourne Hospital
Parkville, 3150, Australia
Related Publications (1)
Zentner D, Pedagogos E, Yapanis A, Karapanagiotidis S, Kinghorn A, Alexiou A, Lee G, Raspudic M, Aggarwal A. Can losartan and blood pressure control peri arteriovenous fistula creation ameliorate the early associated left ventricular hypertrophic response a randomised placebo controlled trial. BMC Res Notes. 2012 May 29;5:260. doi: 10.1186/1756-0500-5-260.
PMID: 22642740DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anuradha Aggarwal
Melbourne Health
- PRINCIPAL INVESTIGATOR
Eugenia Pedagogos, FRACP,PhD
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 8, 2007
First Posted
January 28, 2008
Study Start
October 1, 2006
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
May 12, 2015
Record last verified: 2015-05