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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12607000042448 |
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Date of registration:
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12/01/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epoetin and cardiac function:An echocardiographic analysis in patients with heart failure.
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Scientific title:
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Improved cardiac function following the acute intravenous administration of epoetin alpha in patients with heart failure. An echocardiographic, placebo controlled study. |
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Date of first enrolment:
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01/08/2006 |
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Target sample size:
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12 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12607000042448.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Contacts
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Name:
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Shane Lachlan Carney
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Address:
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Department of Nephrology
John Hunter Hospital
Locked Bag No 1
Hunter Region Mail Centre NSW 2310
Australia |
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Telephone:
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+61 2 49214333 |
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Email:
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Shane.Carney@hnehealth.nsw.gov.au |
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Affiliation:
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Name:
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Bruce Bastian
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Address:
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Depertment of Cardiovascular Medicine
Locked Bag No 1
Newcastle Mail Centre NSW 2310
Australia |
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Telephone:
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+61 2 49214207 |
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Email:
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Bruce.Bastian@hnehealth.nsw.gov.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Any form of cadiac failure.
Exclusion criteria: Allergy to epoetin alpha.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Cardiovascular - Other cardiovascular diseases
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Cardiac failure.;
Cardiac failure.
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Intervention(s)
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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.
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Primary Outcome(s)
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Improved cardiac function including increased ejection fraction (echocardiography)[At 45 & 120 mins.]
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Secondary ID(s)
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Therapeutic Goods Administration (TGA): 2006/100
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Therapeutic Goods Administration (TGA): Protocol Number: V1 16MAY2005
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Source(s) of Monetary Support
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Janssen Cilag Pty Ltd.
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Hunter Area Health Service
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Ethics review
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Status: Not approved
Approval date:
Contact:
John Hunter Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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