Attenuation of Cardiac Effects of Arteriovenous Fistula Creation With Losartan

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2006 by Melbourne Health
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00602004
First received: March 8, 2007
Last updated: May 28, 2013
Last verified: June 2006
  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 (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early and Late Cardiac Effects of Arteriovenous Fistula Creation for Haemodialysis in End-stage Renal Failure and Their Possible Attenuation

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • left ventricular hypertrophy [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: October 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: losartan
    losartan 50 mg a day
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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Melbourne Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Anuradha Aggarwal, Royal Melbourne Hospital
ClinicalTrials.gov Identifier: NCT00602004     History of Changes
Other Study ID Numbers: 2006.059
Study First Received: March 8, 2007
Last Updated: May 28, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Melbourne Health:
Arteriovenous fistula
hypertrophy
losartan

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Hypertrophy
Kidney Failure, Chronic
Renal Insufficiency
Hypertrophy, Left Ventricular
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Renal Insufficiency, Chronic
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 August 28, 2014