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Trial registered on ANZCTR
Registration number
ACTRN12609000053224
Ethics application status
Approved
Date submitted
17/01/2009
Date registered
23/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Potential therapy for left ventricular hypertrophy in diabetic heart disease
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Scientific title
Pilot study of the effects on cardiac diastolic function of GC811007, a fructosamine oxidase inhibitor, in patients with Type 2 diabetes and diabetic cardiomyopathy
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Universal Trial Number (UTN)
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Trial acronym
INFO-CARDIAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Left-ventricular hypertrophy in type-2 diabetic patients
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Oral administration of trientine[Triethylenetetramine dihydrochloride] 600 mg twice daily p.o. (two 300 mg capsules twice daily) before breakfast and
evening meal.
Duration period: 12 months.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
Placebo: Equivalent weight of microcellulose contained in identical capsules.
Mode of administration of placebo: Identical to that of active drug, namely
600 mg twice daily p.o. (two 300 mg capsules twice daily) before breakfast
and evening meals.
Duration of placebo dose: 12 months.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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left ventricle mass indexed to body surface area (LVMbsa) after six and 12 months of therapy as determined by cardiac
magnetic resonance imaging (cMRI).
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Assessment method [1]
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Timepoint [1]
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at baseline and at 6, 12 months after randomisation
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Primary outcome [2]
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Change in early mitral annular velocity (Em) as determined by echocardiography (ECHO)
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Assessment method [2]
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Timepoint [2]
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at baseline and at 6 months after randomisation
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Primary outcome [3]
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Change in LV apical rotation at 140% of systole as determined by cMRI
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Assessment method [3]
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Timepoint [3]
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at baseline and at 6, 12 months after randomisation
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Secondary outcome [1]
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Change in urinary copper excretion
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Assessment method [1]
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Timepoint [1]
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after four months
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Eligibility
Key inclusion criteria
Age between 30 and 70 years; known type 2 diabetes; HbA1c > 7.0% at enrollment; normal electrocardiogram; abnormal diastolic filling as demonstrated by mitral inflow Doppler with pre-load reduction LV ejection fraction = 45% by echocardiography, with evidence of diastolic dysfunction but no regional wall-motion abnormalities; no new medications for six months prior to randomization with no change of ß-blocker dose during that period.
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Minimum age
30
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Morbid obesity (BMI = 45 kg.m-2); type 1 diabetes; history or evidence of diabetic retinopathy and/or diabetic nephropathy (serum creatinine > 150 µmol/l and/or urinary albumin > 300 mg/l); autonomic neuropathy; significant cardiac valvular disease; LV wall motion abnormality by echocardiography; history of significant malabsorption; multiple drug allergies; use or misuse of substances of abuse; evidence of abnormal electrolyte homeostasis or renal, hepatic or thyroid function; or standard contraindications to MRI
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a double blind randomized trial. Patients enrolled from a hospital clinic in Auckland, NZ following completion of written consent. Prior to randomization to treatment, patients completed a 4 week single-blind run-in period of 2 placebo capsules twice daily, for which = 90% compliance was required for progression into the trial. Patients meeting inclusion criteria then randomized to receive trientine or identical placebo capsules. Treatment
assignment was performed centrally using variable block sizes to ensure
balance throughout trial recruitment and numbered drug packs were
prepared and dispensed sequentially to randomized patients
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order of subject enrollment into treatment groups without stratification was performed by permuted block randomisation to ensure balance throughout enrollment, using a computer software programme contained with SAS v8.01 (SAS Institute, Cary, NC, USA)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
14/03/2001
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Protemix Corporation
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Address [1]
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P O Box 2165
Auckland 1140
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Country [1]
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New Zealand
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Primary sponsor type
Commercial sector/Industry
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Name
Protemix Corporation
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Address
P O Box 2165
Auckland 1140
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Auckland Ethics Committee
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Ethics committee address [1]
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650 Great South Road,
Penrose,
Auckland 1061
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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15/12/2000
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Ethics approval number [1]
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2000/188
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Summary
Brief summary
This study was designed to assess the effects of the drug triethylenetetramine dihydrochloride on cardiac dysfunction in patients with type 2 diabetes (T2DM) and demonstrable cardiac dysfunction. Previous treatment of diabetic rats has shown significant improvement in structure and function of the heart, including alleviation of heart failure through significant cardiac regeneration, and clinical studies have shown that TETA.2HCl may work through chelation and excretion of copper (Cu) in urine. This study was designed to measure indices of cardiac structure over a 12 month intervention period and hypothesized that markers of diastolic dysfunction in T2DM would be improved on treatment versus placebo.
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Trial website
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Trial related presentations / publications
Diabetologia, MS 08 1484 in final edit
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Associate-Professor Sally Poppitt
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Address
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School of Biological Sciences,
University of Auckland
Private Bag 92 109
Auckland 1142
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Country
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New Zealand
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Phone
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+64 (09) 6305160
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Fax
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+64 (9) 373 7045
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Email
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[email protected]
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Contact person for scientific queries
Name
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Professor Garth Cooper
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Address
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School of Biological Sciences,
University of Auckland
Private Bag 92 109
Auckland 1142
Auckland
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Country
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New Zealand
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Phone
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+64 (9) 373 7599 Ext 87394
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Fax
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+64 (9) 373 7045
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
A copper(II)-selective chelator ameliorates left-ventricular hypertrophy in type 2 diabetic patients: A randomised placebo-controlled study.
2009
https://dx.doi.org/10.1007/s00125-009-1265-3
N.B. These documents automatically identified may not have been verified by the study sponsor.
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