Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000146998
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
8/02/2011
Date last updated
15/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting the Response of Treatment in Cardiomyopathy
Scientific title
Predictors of Response to Therapy in New-Presentation Idiopathic Dilated Cardiomyopathy
Secondary ID [1] 253562 0
None
Universal Trial Number (UTN)
U1111-1119-2785
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Dilated Cardiomyopathy 261102 0
Condition category
Condition code
Cardiovascular 259235 259235 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
6-minute walk test, Minnesota Living with Heart Failure Questionnaire, NYHA classification, Cardiopulmonary exercise testing, Echocardiogram and CMR will all be performed at baseline, 6 months and 12 months. To complete all these investigations would take approximately 2 hours, at each time point. We will examine the relationship between these parameters and response to conventional heart failure therapy.
Intervention code [1] 257971 0
Not applicable
Comparator / control treatment
nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262068 0
The primary aim of the project is to measure the prognostic significance of myocardial fibrosis in new presentation idiopathic dilated cardiomyopathy (DCM) using cardiac magnetic resonance (CMR).
Timepoint [1] 262068 0
Baseline, 6 months and 12 months
Secondary outcome [1] 273086 0
Determine the prevalence, severity and prognostic significance of inter- and intra-left ventricular mechanical dyssynchrony in new presentation DCM using advanced echocardiography techniques.
Timepoint [1] 273086 0
Baseline, 6 months and 12 months
Secondary outcome [2] 273087 0
Assess the utility of serum biomarkers of myocardial fibrosis, such as matrix metalloproteinases (MMPs) and the tissue inhibitors of matrix metalloproteinase (TIMPs), in the prediction of prognosis in new presentation DCM.
Timepoint [2] 273087 0
Baseline, 6 months and 12 months

Eligibility
Key inclusion criteria
Clinical heart failure (New York Heart Association class II - IV) on first presentation, LV ejection fraction <45% as measured by echocardiography, ventriculography, or cardiac
scintigraphy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Standard MRI contraindications, including permanent pacemaker, implantable defibrillator,
severe claustrophobia, Significant coronary artery disease, as manifest by >70% stenosis in a major epicardial
coronary artery or the presence of a moderate or greater zone of ischaemia/infarction on
stress imaging, Concomitant valvular heart disease as a cause or central contributor to the heart failure
(excluding functional mitral regurgitation, Hypertrophic obstructive cardiomyopathy, Myocarditis, amyloidosis, sarcoidosis, uncontrolled thyroid disease, post-partum
cardiomyopathy, Renal impairment (eGFR <60ml/min) will be an exclusion criterion from the administration
of gadolinium, New York Heart Association class IV symptoms (i.e. dyspnoea at rest), and unstable
ischaemic heart disease will be exclusion criteria from cardiopulmonary exercise testing

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258428 0
Hospital
Name [1] 258428 0
Flinders Medical Center
Country [1] 258428 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Address
Department Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country
Australia
Secondary sponsor category [1] 257576 0
None
Name [1] 257576 0
Address [1] 257576 0
Country [1] 257576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260412 0
Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 260412 0
Human Research Ethics
Southern Adelaide Health Service
SA Health
Room 2A221 - Inside Human Resources
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Ethics committee country [1] 260412 0
Australia
Date submitted for ethics approval [1] 260412 0
16/04/2008
Approval date [1] 260412 0
05/06/2008
Ethics approval number [1] 260412 0
74/08

Summary
Brief summary
Heart Failure (HF) is a leading cause of heart disease and mortality in developed countries. It is the leading reason for hospital admission among patients over 65 years and the most costly cardiovascular disorder in Western countries. A first hospital admission for HF has been shown to confer a worse prognosis than a first admission for bowel or breast cancer. The burden of HF is expected to increase in Australia due to the ageing population and improved survival from acute cardiac events. New cardiac imaging tools, such as cardiac MRI and novel applications of echocardiography (ultrasound of the heart), now permit an insight into some of the fundamental processes that underlie why some individuals don’t respond to conventional HF treatment. In particular, our research will focus on the scarring within the heart muscle, and the loss of coordination of the heart as it pumps, in perpetuating the vicious HF cycle. Furthermore, we will explore the role of a simple blood test, to measure markers of scarring from the heart, in predicting patient outcomes in the setting of a new diagnosis of HF. An understanding of these elements in the pathogenesis of cardiomyopathy will help clarify the mechanistic cascade of HF, and may thus lead to novel therapies to interrupt such an adverse process. This research may thus change the way cardiomyopathy is viewed and treated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32168 0
Address 32168 0
Country 32168 0
Phone 32168 0
Fax 32168 0
Email 32168 0
Contact person for public queries
Name 15415 0
Kate Schwartz
Address 15415 0
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 15415 0
Australia
Phone 15415 0
+61 8 8201 7700
Fax 15415 0
+61 8 8201 7701
Email 15415 0
[email protected]
Contact person for scientific queries
Name 6343 0
Dr Darryl Leong
Address 6343 0
University of Adelaide
C/O -
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 6343 0
Australia
Phone 6343 0
+61 8 8201 7700
Fax 6343 0
+61 8 8201 7701
Email 6343 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
No additional documents have been identified.