ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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

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]

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

Condition category

Condition code

Cardiovascular

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]

Not applicable

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Baseline, 6 months and 12 months

Secondary outcome [1]

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]

Baseline, 6 months and 12 months

Secondary outcome [2]

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]

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?

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]

Hospital

Name [1]

Flinders Medical Center

Address [1]

Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Adelaide Health Service / Flinders University Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

16/04/2008

Approval date [1]

05/06/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Kate Schwartz

Address

Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042

Country

Australia

Phone

+61 8 8201 7700

Fax

+61 8 8201 7701

kate.schwartz@health.sa.gov.au

Contact person for scientific queries

Name

Dr Darryl Leong

Address

University of Adelaide
C/O -
Flinders Clinical Research
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042

Country

Australia

Phone

+61 8 8201 7700

Fax

+61 8 8201 7701

darryl.leong@adelaide.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.

Trial Review

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