Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610001063000
Ethics application status
Approved
Date submitted
21/10/2010
Date registered
2/12/2010
Date last updated
11/12/2017
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
Nil
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
Diabetes
Cardiovascular 258701 258701 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Prevention
Intervention code [2] 257428 0
Treatment: Drugs
Comparator / control treatment
Oral placebo (lactose based pills) once daily for 12 months
Control group
Placebo

Outcomes
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
Nil
Timepoint [1] 265999 0
Nil

Eligibility
Key inclusion criteria
Type II diabetes mellitus
Stable metabolic control
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2011
Actual
2/11/2011
Date of last participant enrolment
Anticipated
31/12/2014
Actual
23/03/2015
Date of last data collection
Anticipated
Actual
29/01/2016
Sample size
Target
130
Accrual to date
Final
140
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
Country [1] 257864 0
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street,
Liverpool, NSW 2170
Country
Australia
Secondary sponsor category [1] 257105 0
None
Name [1] 257105 0
No secondary sponsor
Address [1] 257105 0
No secondary sponsor
Country [1] 257105 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 259897 0
Approval date [1] 259897 0
20/08/2010
Ethics approval number [1] 259897 0
HREC/10/CRGH/62

Summary
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

Contacts
Principal investigator
Name 31793 0
Prof Dominic Leung
Address 31793 0
Department of Cardiology, Liverpool Hospital, Liverpool, NSW 2170
Country 31793 0
Australia
Phone 31793 0
+61287383797
Fax 31793 0
Email 31793 0
[email protected]
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
Australia
Phone 15040 0
+61 2 87383797
Fax 15040 0
+61 2 87383054
Email 15040 0
[email protected]
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
Australia
Phone 5968 0
+61 2 87383797
Fax 5968 0
+61 2 8733054
Email 5968 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
SourceTitleYear of PublicationDOI
Dimensions AIRationale and design of a randomized trial on the impact of aldosterone antagonism on cardiac structure and function in diabetic cardiomyopathy2013https://doi.org/10.1186/1475-2840-12-139
N.B. These documents automatically identified may not have been verified by the study sponsor.