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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Early detection and echocardiographic assessment of diabetic heart disease and the impact of neurohormonal inhibition
Scientific title
Echocardiographic assessment and early detection of heart muscle disease in patients with type II diabetes and the impact of neurohormonal inhibition compared with placebo on heart function
Secondary ID [1] 252899 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes mellitus 258433 0
Condition category
Condition code
Metabolic and Endocrine 258595 258595 0 0
Cardiovascular 258701 258701 0 0
Other cardiovascular diseases

Study type
Description of intervention(s) / exposure
Eligible patients (about 130 patients) with type II diabetes mellitus with stable metabolic control will be randomised to elperenone or matching placebo. Initial dose will be one tablet a day orally (25 mg). The dose may be up titrated to 50 mg daily after 4 weeks if the lower dose is tolerated. All patients will be monitored regularly for side effects and blood tests will be obtained to monitor serum electrolytes levels and renal function. Treatment will be maintained for a minimum of 12 months. Heart muscle function and degree of scarring will be assessed with echocardiography at baseline and again at 12 months. Biomarkers levels of collagen synthesis will be assessed at baseline and at 12 months
Intervention code [1] 257427 0
Intervention code [2] 257428 0
Treatment: Drugs
Comparator / control treatment
Oral placebo (lactose based pills) once daily for 12 months
Control group

Primary outcome [1] 259446 0
Left ventricular and left atrial function by echocardiogram ultrasound
Timepoint [1] 259446 0
Patients will be screened on enrolment before randomisation and then 12 month after enrolment
Primary outcome [2] 259564 0
Degree of scarring of the left ventricle and left atrium by echocardiography
Timepoint [2] 259564 0
Patients will be screened on enrolment before randomisation and then 12 month after enrolment
Primary outcome [3] 259637 0
Biomarkers of collagen synthesis
Timepoint [3] 259637 0
At baseline and at 12 months after enrolment
Secondary outcome [1] 265999 0
Timepoint [1] 265999 0

Key inclusion criteria
Type II diabetes mellitus
Stable metabolic control
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Severe heart failure
Chronic kidney diseases (serum creatinine > 220 umol/L)
Hyperkalaemia (serum potassium > 5 mmol/L)
Addison's disease

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients will be approached by the investigators, informed written consent obtained and patients will then be randomised after initial echocardiogram and blood tests. It is a double blind randomised placebo controlled trial and only the trial pharmacist will be aware of treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using a permuted blocks design. Centralised randomisation will occur via a password protected computer program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 5218 0
Liverpool Hospital - Liverpool

Funding & Sponsors
Funding source category [1] 257864 0
Self funded/Unfunded
Name [1] 257864 0
Address [1] 257864 0
Country [1] 257864 0
Primary sponsor type
Liverpool Hospital
Elizabeth Street,
Liverpool, NSW 2170
Secondary sponsor category [1] 257105 0
Name [1] 257105 0
No secondary sponsor
Address [1] 257105 0
No secondary sponsor
Country [1] 257105 0

Ethics approval
Ethics application status
Ethics committee name [1] 259897 0
Sydney Southwest Area Health Service Human Research Ethics Committee, Concord Repatriation Hospital
Ethics committee address [1] 259897 0
Concord Hospital
Concord, NSW, 2139
Ethics committee country [1] 259897 0
Date submitted for ethics approval [1] 259897 0
Approval date [1] 259897 0
Ethics approval number [1] 259897 0

Brief summary
The primary purpose is to assess the ability of new techniques of echocardiographic assessment of heart function in detecting early heart disease in patients with type II diabetes mellitus and to assess the impact of 12 month period of neurohormonal inhibition in improving heart muscle function and degree of scarring in these patients
Trial website
Trial related presentations / publications
Leung M, Wong V, Heritier S, Mihailidou AS, Leung DY. Rationale and design of a randomized trial on the impact of aldosterone antagonism on cardiac structure and function in diabetic cardiomyopathy. Cardiovascular Diabetology, 2013;12:139. doi:10.1186/1475-2840-12-139
Public notes

Principal investigator
Name 31793 0
Prof Dominic Leung
Address 31793 0
Department of Cardiology, Liverpool Hospital, Liverpool, NSW 2170
Country 31793 0
Phone 31793 0
Fax 31793 0
Email 31793 0
Contact person for public queries
Name 15040 0
Prof Professor Dominic Leung
Address 15040 0
Department of Cardiology
Elizabeth Street
Liverpool Hospital
Liverpool, NSW 2170
Country 15040 0
Phone 15040 0
+61 2 87383797
Fax 15040 0
+61 2 87383054
Email 15040 0
Contact person for scientific queries
Name 5968 0
Prof Professor Dominic Leung
Address 5968 0
Department of Cardiology
Elizabeth Street
Liverpool Hospital
Liverpool, NSW 2170
Country 5968 0
Phone 5968 0
+61 2 87383797
Fax 5968 0
+61 2 8733054
Email 5968 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary