Trial Review

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Trial registered on ANZCTR


Registration number
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
Sex
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
1/07/2003
Actual
10/07/2003
Date of last participant enrolment
Anticipated
Actual
31/05/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
64
Accrual to date
Final
64
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
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
Trial website
Trial related presentations / publications
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
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
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

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.