Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000655246
Ethics application status
Approved
Date submitted
14/07/2009
Date registered
4/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of aldosterone blockade to improve cardiac function in obesity
Scientific title
Use of aldosterone blockade to improve cardiac function in obesity
Universal Trial Number (UTN)
Trial acronym
OB02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diastolic Dysfunction 237241 0
Myocardial fibrosis 237242 0
Condition category
Condition code
Cardiovascular 239567 239567 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spironolactone 25mg
Oral tablets, once a day for a total of 26 weeks.
Intervention code [1] 236933 0
Treatment: Drugs
Comparator / control treatment
Oral placebo tablet containing lactose, once a day for a total of 26 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 238360 0
Myocardial fibrosis.
Cardiac Magnetic Resonance Imaging (MRI) will be performed on a 1.5 Tesla GE Signa scanner using Electrocardiography (ECG) gating, dedicated cardiac coils, and commercially available software. Initial localiser sequences are followed by b-SSFP cine sequences in the vertical long axis, horizontal long axis, and left ventricular short axis. A comprehensive functional study will be performed followed by myocardial characterisation with T1 and T2 weighted imaging, quantification of T2*. Following this resting myocardial perfusion will be assessed following administration of intravenous contrast (containing Gadolinium), then delayed contrast enhanced MRI will be performed to assess fibrosis.
Timepoint [1] 238360 0
Baseline and post intervetion (26 weeks)
Secondary outcome [1] 244793 0
Diastolic function.
A resting echo will be performed using a commercially available Vivid 7. A variable-frequency phased array transducer will be used for all two-dimensional, M-mode and Doppler examinations. Tissue Doppler/strain: Color myocardial tissue Doppler will be obtained with frame-rates set at >110 frames/sec, with a pulse repetition frequency between 500Hz to 1KHz, resulting in aliasing velocity >16 cm/sec. Digital storage of three sequential cardiac cycle loops triggered to the QRS complex will be saved to magneto-optical disk for off-line analysis of backscatter and strain.
Timepoint [1] 244793 0
Baseline and post intervetion (26 weeks)
Secondary outcome [2] 244794 0
Biochemistry.
Collagen biomarkers (PICP, PINP, PIIINP) will be measured by immunoassay as surrogate measures of myocardial fibrosis.
Timepoint [2] 244794 0
Baseline and post intervetion (26 weeks)

Eligibility
Key inclusion criteria
Obesity: Body mass index (BMI) > 30
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetes, cardiovascular disease or other chronic disease

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)
Random number-based randomization attached to the study database
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2009
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] 237324 0
Government body
Name [1] 237324 0
National Health and Medical Research Council (NHMRC)
Country [1] 237324 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 236930 0
Other Collaborative groups
Name [1] 236930 0
Centre for Clinical Research Excellence (CCRE)
Address [1] 236930 0
Princess Alexandra Hospital, 4th Floor, blg 1
Ipswich Road, Brisbane Qld 4102
Country [1] 236930 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239424 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 239424 0
Ethics committee country [1] 239424 0
Australia
Date submitted for ethics approval [1] 239424 0
10/02/2009
Approval date [1] 239424 0
04/06/2009
Ethics approval number [1] 239424 0
2009/025
Ethics committee name [2] 239425 0
the University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 239425 0
Ethics committee country [2] 239425 0
Australia
Date submitted for ethics approval [2] 239425 0
20/06/2009
Approval date [2] 239425 0
06/07/2009
Ethics approval number [2] 239425 0
2009001186

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

Contacts
Principal investigator
Name 29895 0
Address 29895 0
Country 29895 0
Phone 29895 0
Fax 29895 0
Email 29895 0
Contact person for public queries
Name 13142 0
Trisha O'Moore-Sullivan
Address 13142 0
Diabetes and Endocrinology, Ground Floor, Building 1, Princess Alexandra Hospital
Ipswich Road, Brisbane Qld 4102
Country 13142 0
Australia
Phone 13142 0
+61 7 3240 2690
Fax 13142 0
Email 13142 0
t.omooresullivan@uq.edu.au
Contact person for scientific queries
Name 4070 0
Trisha O'Moore-Sullivan
Address 4070 0
Diabetes and Endocrinology, Ground Floor, Building 1, Princess Alexandra Hospital
Ipswich Road, Brisbane Qld 4102
Country 4070 0
Australia
Phone 4070 0
+61 7 3240 2690
Fax 4070 0
Email 4070 0
t.omooresullivan@uq.edu.au

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
SourceTitleYear of PublicationDOI
Dimensions AIFibrosis and cardiac function in obesity: a randomised controlled trial of aldosterone blockade2013https://doi.org/10.1136/heartjnl-2012-303329
N.B. These documents automatically identified may not have been verified by the study sponsor.