Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000727448
Ethics application status
Approved
Date submitted
22/05/2016
Date registered
2/06/2016
Date last updated
2/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac MRI in the prediction of outcomes in advanced cardiomyopathy
Scientific title
Cardiac MRI in the prediction of outcomes in advanced cardiomyopathy
Secondary ID [1] 285944 0
Nil
Universal Trial Number (UTN)
U1111-1165-9147
Trial acronym
PREDICT-MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 293869 0
Sudden cardiac death 293870 0
Arrhythmia 293871 0
Cardiac fibrosis 293872 0
Condition category
Condition code
Cardiovascular 294174 294174 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Cardiomyopathy - both newly diagnosed and established. Both ischaemic and non-ischaemic. We will follow outcomes for 5 years. Patients undergo a cardiac MRI evaluating heart function including the presence of focal and diffuse scarring, left ventricular function, and chamber dimensions. Follow up will be via assessment of the avaialble medical records.
Intervention code [1] 290919 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293966 0
Death will be assessed by review of the medical records and confirmed with reference to publicly available official registries (e.g. Registry of Births Death and Marriages)
Timepoint [1] 293966 0
0, 6, 12, 24, 36, 48, 60 months
Primary outcome [2] 293967 0
Sudden cardiac death - assessed by evaluation of the official cause of death on death certificate or coroners report and complemented with further information from the relevant medical record where available.
Timepoint [2] 293967 0
0, 6, 12, 24, 36, 48, 60 months
Primary outcome [3] 293968 0
Aborted sudden cardiac death (survived cardiac arrest) - assessed by review of the medical record for the relevant admission, or by review of ICD interrogation data (ie stored interrogation data) - in the setting of appropriate therapy for VT of VF.
Timepoint [3] 293968 0
0, 6, 12, 24, 36, 48, 60 months
Secondary outcome [1] 312249 0
All cause mortality
Timepoint [1] 312249 0
0, 6, 12, 24, 36, 48, 60 months
Secondary outcome [2] 312250 0
Documented ventricular tachycardia or ventricular fibrillation - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).
Timepoint [2] 312250 0
0, 6, 12, 24, 36, 48, 60 months
Secondary outcome [3] 312251 0
New onset other arrhythmias (AF, SVT, other) - - as documented in the medical record (ECG, 24hr holter, cardiac device interrogation).
Timepoint [3] 312251 0
0, 6, 12, 24, 36, 48, 60 months
Secondary outcome [4] 312252 0
Left Ventricular Ejection Fraction - as documented in subsequent transthoracic echocardiograms, gated blood pool scans, other cardiac MRI, LV angiography or any other validated LV ejection function assessment.
Timepoint [4] 312252 0
0, 6, 12, 24, 36, 48, 60 months
Secondary outcome [5] 312253 0
Functional status as determined by he New York Heart Association Scale - as determined by the medical record.
Timepoint [5] 312253 0
0, 6, 12, 24, 36, 48, 60 months

Eligibility
Key inclusion criteria
1. Age > 18
2. Capable of giving informed consent
3. New or established ICM or NICM (LVEF < or = 45%) as detected on any cardiac imaging (echocardiogram, nuclear medicine scan, other cardiac MRI, LV angiogram)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to consent to study
2. Contraindication to cardiac MRI (eg, existing ICD, uncontrollable claustrophobia, inability to lie flat, proven or suspected metallic implant)
3. eGRF < 35ml/min or Cr > 220
4. Pregnancy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Using a non-inferiority margin of 2.0 for the hazard ratio of ICD implantation to no ICD implantation in NICM patients without myocardial scar, and assuming a similar 3-year mortality to that published in prior studies, approximately 240 patients would need to be enrolled (120 with a primary prevention ICD and 120 without) to achieve a statistical power of 0.8. We have previously demonstrated a high rate of appropriate ICD discharge of approximately 15% per year. 1 Assuming approximately half of these discharges were life saving, 110 patients in each group will deliver a power of 80% with an alpha value of 5%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
30/04/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5826 0
The Alfred - Prahran
Recruitment hospital [2] 5827 0
Monash Medical Centre - Clayton campus - Clayton

Funding & Sponsors
Funding source category [1] 293647 0
Other
Name [1] 293647 0
Baker IDI Heart and Diabetes Institute
Country [1] 293647 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart and Diabetes Institute
Address
75 Commercial Road
Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 292481 0
None
Name [1] 292481 0
Address [1] 292481 0
Country [1] 292481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295083 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 295083 0
55 Commercial Road
Melbourne, VIC, 3004
Ethics committee country [1] 295083 0
Australia
Date submitted for ethics approval [1] 295083 0
22/01/2015
Approval date [1] 295083 0
21/04/2015
Ethics approval number [1] 295083 0
7/15

Summary
Brief summary
Nearly 50% of patients with systolic heart failure suffer sudden cardiac death (SCD). In patients with ischaemic cardiomyopathy (ICM) and an LV ejection fraction (LVEF) of <30%, primary prevention ICD implantation reduced mortality at 20 months follow-up compared to medical therapy alone. Trials in NICM patients suggested similar findings but failed to reach statistical significance - statistical significance was only achieved when both ICM and NICM groups were combined. urrent clinically based guidelines focus on the importance of symptoms (NYHA Class) and LVEF in determining suitability for ICD implantation. Nonetheless, ICD implantation, despite its mortality benefit in selected patient populations, infers significant morbidity in terms or device related complications including tamponade, infections, inappropriate device therapy (which itself has been linked to increased mortality). Consequently, uptake of prophylactic ICD therapy in Australia has been variable with many major centres failing to comply with international guidelines. Hence, many authors have called for the urgent re-evaluation of current guidelines. Clearly there is a need for further risk stratification to assess the vulnerability of the heart failure population to sudden cardiac death, and other long term morbidities associated with the condition.
Myocardial fibrosis is a fundamental event in the development of cardiac failure, and is a common feature in all patients with advanced cardiac failure regardless of the aetiology of cardiomyopathy. Myocardial fibrosis in animal models is associated with worsening ventricular systolic function, abnormal cardiac remodelling and may predispose to ventricular arrhythmia. Also, increasing myocardial fibrosis results in progressive deterioration of myocardial function, with more extensive myocardial fibrosis identified histologically in the hearts of patients with advanced heart failure. Cardiac fibrosis has been identified as a key component of remodelling associated particularly idiopathic cardiomyopathy and our group has demonstrated a clear association with arrhythmogenesis (including VT and VF) in patients with systolic heart failure. For example, recently, our group published compelling data supporting the role of contrast-enhanced cardiac magnetic resonance imaging (CMR) in identifying low risk patients who meet current criteria for ICD implantation yet are unlikely to benefit this intervention. We feel that the cardiac MRI evaluation, particularly its ability to detect both regional and diffuse fibrosis, may be a useful tool in predicting the outcomes of patients with heart failure.
This trail seeks to establish a long term prospective data registry to evaluate predictive value of CMR in determining the long term outcome of patients with advanced cardiomyopathy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53926 0
A/Prof Andrew J Taylor
Address 53926 0
Head Cardiac MRI
Alfred Hospital and Baker IDI
75 Commercial Road
Melbourne, VIC, 3004
Country 53926 0
Australia
Phone 53926 0
+61390762000
Fax 53926 0
Email 53926 0
[email protected]
Contact person for public queries
Name 53927 0
Dr Sandeep Prabhu
Address 53927 0
Alfred Hospital Heart Centre
3rd Floor Philip Block
The Alfred
55 Commercial Road
Prahran, VIC, 3181
Country 53927 0
Australia
Phone 53927 0
+61 3 90762000
Fax 53927 0
Email 53927 0
[email protected]
Contact person for scientific queries
Name 53928 0
A/Prof Andrew J Taylor
Address 53928 0
Head Cardiac MRI
Alfred Hospital and Baker IDI
75 Commercial Road
Melbourne, VIC, 3004
Country 53928 0
Australia
Phone 53928 0
+61 3 90762000
Fax 53928 0
Email 53928 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

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