Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000042448
Ethics application status
Approved
Date submitted
25/07/2006
Date registered
12/01/2007
Date last updated
12/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Epoetin and cardiac function:An echocardiographic analysis in patients with heart failure.
Scientific title
Improved cardiac function following the acute intravenous administration of epoetin alpha in patients with heart failure. An echocardiographic, placebo controlled study.
Secondary ID [1] 329 0
Therapeutic Goods Administration (TGA): 2006/100
Secondary ID [2] 330 0
Therapeutic Goods Administration (TGA): Protocol Number: V1 16MAY2005
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac failure. 1535 0
Condition category
Condition code
Cardiovascular 1632 1632 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous administration of epoetin alpha(10,000U)and subsequent echocardiography(45 & 120 min later)-then after a 135 min washout period,a small volume ( 1 ml)normal saline ( placebo) is given followed by repeat echocardiography 45 & 120 min later.Trial drug and placebo given only once.
Intervention code [1] 1227 0
Treatment: Drugs
Comparator / control treatment
After a 135 min washout period,a small volume ( 1 ml)normal saline ( placebo) is given followed by repeat echocardiography 45 & 120 min later.
Control group
Placebo

Outcomes
Primary outcome [1] 2255 0
Improved cardiac function including increased ejection fraction (echocardiography)
Timepoint [1] 2255 0
At 45 & 120 mins.
Secondary outcome [1] 3929 0
Nil
Timepoint [1] 3929 0

Eligibility
Key inclusion criteria
Any form of cadiac failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Allergy to epoetin alpha.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nurse giving I/V injection not involved in study analysis.Use of sealed numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin tossing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Subject ,echocardiographer , person performing pulse wave velocity are blinded.Only nurse who gives i/v placebo or epoetin is aware but has no role in study analysis.
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1778 0
Government body
Name [1] 1778 0
Hunter Area Health Service
Country [1] 1778 0
Australia
Funding source category [2] 1779 0
Commercial sector/Industry
Name [2] 1779 0
Janssen Cilag Pty Ltd.
Country [2] 1779 0
United Kingdom
Primary sponsor type
Hospital
Name
Departments of Cardiovascular Medicine and Nephrology,John Hunter Hospital.
Address
Country
Australia
Secondary sponsor category [1] 1583 0
Commercial sector/Industry
Name [1] 1583 0
Janssen Cilag Pty Ltd.
Address [1] 1583 0
Country [1] 1583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3334 0
John Hunter Hospital
Ethics committee address [1] 3334 0
Ethics committee country [1] 3334 0
Australia
Date submitted for ethics approval [1] 3334 0
Approval date [1] 3334 0
Ethics approval number [1] 3334 0
04/12/08/3.19

Summary
Brief summary
A preliminary study to evaluate the acute effect (2 hours) of a commonly used treatment for anaemia in renal failure on cardiac function (strength) in patients with cardiac failure.The potential benefits are based on a recent study(unpublished) that observed an effect of intravenous epoetin alpha on heart and large blood vessel (aorta) function.Patient and echocardiographer blinded to treatment/placebo order.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35229 0
Address 35229 0
Country 35229 0
Phone 35229 0
Fax 35229 0
Email 35229 0
Contact person for public queries
Name 10416 0
Shane Lachlan Carney
Address 10416 0
Department of Nephrology
John Hunter Hospital
Locked Bag No 1
Hunter Region Mail Centre NSW 2310
Country 10416 0
Australia
Phone 10416 0
+61 2 49214333
Fax 10416 0
+61 2 49214339
Email 10416 0
[email protected]
Contact person for scientific queries
Name 1344 0
Bruce Bastian
Address 1344 0
Depertment of Cardiovascular Medicine
Locked Bag No 1
Newcastle Mail Centre NSW 2310
Country 1344 0
Australia
Phone 1344 0
+61 2 49214207
Fax 1344 0
+61 2 49214210
Email 1344 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.