Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000495921
Ethics application status
Approved
Date submitted
10/05/2011
Date registered
11/05/2011
Date last updated
15/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Multi-Parametric Cardiovascular Magnetic Resonance Assessment of Hypertrophic Cardiomyopathy - Therapeutic Metformin sub-study
Scientific title
Multi-Parametric Cardiovascular Magnetic Resonance Assessment of Hypertrophic Cardiomyopathy - Therapeutic Metformin sub-study
Secondary ID [1] 262143 0
None
Universal Trial Number (UTN)
U1111-1121-2660
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic Cardiomopathy 265821 0
Condition category
Condition code
Cardiovascular 265975 265975 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From the main study criteria (ACTRN12611000479909), patients with reduced PCR/ATP ratio of < 1.7 will be eligible to participate in the therapeutic metformin sub-study. They will have a baseline 10ml blood sample before having 12 weeks treatment of either metformin 1g orally 3 x daily or placebo orally 3 x daily before crossing over to the other treatment after a 4 week drug wash-out period. At the end of each 12 week treatment phase they will have another 10ml blood sample, cardiac magnetic resonance imaging with gadolinium contrast (0.025mmol/kg body weight), cardiac magnetic resonance spectroscopy with adenosine intravenously (140mcg/kg/min) for 3-6 mins and echocardiography.
Intervention code [1] 264556 0
Treatment: Drugs
Comparator / control treatment
40 patients will take part in the therapeutic metformin sub-study. In a double-blind randomised control trial manner, they will either receive metformin tablets 1g 3 x daily or placebo tablets 3 x daily for 12 weeks, and be crossed over to the other treatment arm after a 4 week drug wash-out period. Placebo is packed with microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 266721 0
Phosphocreatine (PCr)/Adenosinetriphosphate (ATP) ratio. Method: Cardiac magnetic resonance spectroscopy will be used to measure cardiac high energy phosphate metabolism in-vivo. The novel SLOOP method (spatial localisation with optimum pointspread function) allows accurate measurement of absolute concentrations of high-energy phosphates.
Timepoint [1] 266721 0
28 weeks
Secondary outcome [1] 276246 0
AMPK activity as measured by peripheral blood test
Timepoint [1] 276246 0
28 weeks
Secondary outcome [2] 276247 0
Absolute concentration of high-energy phosphates as measured by cardiac magnetic spectroscopy.
Timepoint [2] 276247 0
28 weeks
Secondary outcome [3] 276248 0
LV diastolic function as measured by cardiac magnetic resonance imaging and doppler echocardiography
Timepoint [3] 276248 0
28 weeks
Secondary outcome [4] 276249 0
Regional function as measured by cardiac magnetic resonance imaging
Timepoint [4] 276249 0
28 weeks
Secondary outcome [5] 276250 0
LV systolic function as measured by cardiac magnetic resonance imaging
Timepoint [5] 276250 0
28 weeks

Eligibility
Key inclusion criteria
Hypertrophic cardiomyopathy patients aged between 18 and 75; phenotype positive (established by echocardiography or cardiac magnetic resonance scan); genotype positive for cardiac myosin binding protein-C gene mutations or cardiac beta-myosin heavy chain gene mutations; patients with reduced baseline PCR/ATP ratio of <1.7
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Impaired LV systolic function (EF <50%) as detected on echocardiography or cardiac magnetic resonance scan; history of diabetes mellitus, calculated GFR <30mls/hr; significant derranged liver function defined as liver enzymes of 3 x ULN; current therapy with metformin or amiodarone; absolute contraindication of having MRI scan.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 265036 0
Charities/Societies/Foundations
Name [1] 265036 0
National Heart Foundation
Country [1] 265036 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Address
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country
Australia
Secondary sponsor category [1] 264134 0
Individual
Name [1] 264134 0
Professor John Horowitz
Address [1] 264134 0
Department of Cardiology
The Queen Elizabeth Hospital
Woodville South, Adelaide
South Australia 5011
Country [1] 264134 0
Australia
Secondary sponsor category [2] 264135 0
Individual
Name [2] 264135 0
Professor Christopher Semsarian
Address [2] 264135 0
Molecular Cardiology, Centenary Institute
Royal Prince Alfred Hospital
Missenden Rd
Camperdown, NSW 2050
Country [2] 264135 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267029 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 267029 0
Ethics committee country [1] 267029 0
Australia
Date submitted for ethics approval [1] 267029 0
09/09/2010
Approval date [1] 267029 0
17/12/2010
Ethics approval number [1] 267029 0
36910

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32594 0
Address 32594 0
Country 32594 0
Phone 32594 0
Fax 32594 0
Email 32594 0
Contact person for public queries
Name 15841 0
Christine Edwards
Address 15841 0
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK SA 5042
Country 15841 0
Australia
Phone 15841 0
+61 8 8204 5656
Fax 15841 0
+61 8 8204 7047
Email 15841 0
[email protected]
Contact person for scientific queries
Name 6769 0
Professor Joseph Selvanayagam
Address 6769 0
Department of Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK SA 5042
Country 6769 0
Australia
Phone 6769 0
+61 8 8404 2195
Fax 6769 0
Email 6769 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.