Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan - Full Text View

Sponsor:	Melbourne Health
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00602004

Purpose

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
Renal Failure Left Ventricular Hypertrophy	Drug: losartan

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: capillary malformation-arteriovenous malformation syndrome Parkes Weber syndrome

MedlinePlus related topics: Fistulas

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Further study details as provided by Melbourne Health:

Primary Outcome Measures:

left ventricular hypertrophy

Estimated Enrollment:	52
Study Start Date:	October 2006
Estimated Study Completion Date:	August 2008

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602004

Contacts

Contact: Anuradha Aggarwal, FRACP,PhD

anuradha.aggarwal@mh.org.au

Locations

Australia
Royal Melbourne Hospital	Recruiting
Parkville, Australia, 3150
Contact: Anuradha Aggarwal, FrACP, PhD 93427133 anuradha.aggarwal@mh.org.au

Sponsors and Collaborators

Melbourne Health

Investigators

Principal Investigator:	Anuradha Aggarwal	Melbourne Health
Principal Investigator:	Eugenia Pedagogos, FRACP,PhD	Melbourne Health

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00602004 History of Changes
Other Study ID Numbers:	2006.059
Study First Received:	March 8, 2007
Last Updated:	January 15, 2008
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Melbourne Health:

Arteriovenous fistula
hypertrophy
losartan

Additional relevant MeSH terms:

Arteriovenous Fistula
Hypertrophy
Renal Insufficiency
Hypertrophy, Left Ventricular
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Fistula
Pathological Conditions, Anatomical

Kidney Diseases
Urologic Diseases
Cardiomegaly
Heart Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012