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Trial registered on ANZCTR


Trial ID
ACTRN12605000204640
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
23/08/2005
Date last updated
4/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of "Early Disease" in Familial Dilated Cardiomyopathy
Scientific title
Evaluation of the efficacy of carvedilol to reduce echocardiographically-determined left ventricular dimensions in asymptomatic individuals with suspected early disease in familial dilated cardiomyopathy.
Secondary ID [1] 287790 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Familial dilated cardiomyopathy 285 0
Condition category
Condition code
Cardiovascular 322 322 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves a randomised, double-blind, placebo-controlled trial to determine whether oral administration of carvedilol over a 6-month period will reduce left ventricular dimensions in asymptomatic individuals who have a family history of dilated cardiomyopathy and echocardiographic changes that are suspected to represent early disease.
Intervention code [1] 209 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 377 0
Reduction in left ventricular end-systolic and/or end-diastolic dimensions after 6 months of intervention when compared with baseline measurements.
Timepoint [1] 377 0
At baseline and after 6 months of intervention.
Secondary outcome [1] 837 0
Clinical evidence of disease progression, with heart failure symptoms and/or worsening of left ventricular contractile function.
Timepoint [1] 837 0
After 6 months of intervention when compared with baseline measurements.

Eligibility
Key inclusion criteria
Positive family history, absence of heart failure symptoms, increased left ventricular end-diastolic diameter (>112% predicted) with or without mild impairment of systolic function (ejection fraction 40-55%).
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic airflow limitation with >20% reversibility, heart rate less than 50 beats per minute, blood pressure <80/50mmHg.

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)
Sequence randomised by Roche Pharmaceuticals who had nothing to do with administering the treatment. Pre-packaged drugs provided by Roche Pharmaceuticals
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SComputer software generated randomisation schedule with blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 379 0
Government body
Name [1] 379 0
NHMRC Program Grant and institutional funds
Address [1] 379 0
NHMRC
Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Victor Chang Cardiac Research Institute
405 Victoria St Darlinghurst NSW 2010
Country [1] 379 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Darlinghurst
Address
384 Victoria St Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 304 0
None
Name [1] 304 0
N/A
Address [1] 304 0
Country [1] 304 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1368 0
St Vincent's Hospital
Ethics committee address [1] 1368 0
Ethics committee country [1] 1368 0
Australia
Date submitted for ethics approval [1] 1368 0
Approval date [1] 1368 0
21/07/2002
Ethics approval number [1] 1368 0

Summary
Brief summary
The objective of this study is to determine whether active treatment with carvedilol will improve short-term echocardiographic in asymptomatic individuals with familial dilated cardiomyopathy.
Trial website
Trial related presentations / publications
Yeoh T, Hayward CS, Benson V, Sheu A, Richmond Z, Feneley MP, Keogh AM, Macdonald P, Fatkin D. A randomised, placebo-controlled trial of carvedilol in early familial dilated cardiomyopathy. Heart Lung Circulation 2011;20:566-573.
Public notes

Contacts
Principal investigator
Name 35904 0
Prof Diane Fatkin
Address 35904 0
Victor Chang Cardiac Research Institute
405 Liverpool St Darlinghurst NSW 2010
Country 35904 0
Australia
Phone 35904 0
+61 2 9295 8618
Fax 35904 0
Email 35904 0
d.fatkin@victorchang.edu.au
Contact person for public queries
Name 9398 0
Prof A/Prof Diane Fatkin
Address 9398 0
Victor Chang Cardiac Research Institute
384 Victoria St
Darlinghurst NSW 2010
Country 9398 0
Australia
Phone 9398 0
+61 2 92958518
Fax 9398 0
+61 2 92958518
Email 9398 0
d.fatkin@victorchang.unsw.edu.au
Contact person for scientific queries
Name 326 0
Prof A/Prof Diane Fatkin
Address 326 0
Victor Chang Cardiac Research Institute
384 Victoria St
Darlinghurst NSW 2010
Country 326 0
Australia
Phone 326 0
+61 2 92958518
Fax 326 0
+61 2 92958518
Email 326 0
d.fatkin@victorchang.unsw.edu.au