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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01918215




Registration number
NCT01918215
Ethics application status
Date submitted
19/04/2013
Date registered
7/08/2013
Date last updated
7/03/2023

Titles & IDs
Public title
Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction.
Scientific title
Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction
Secondary ID [1] 0 0
CMRG-HF-1
Universal Trial Number (UTN)
Trial acronym
CMR_GUIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Left Ventricular Systolic Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ICD
Treatment: Devices - ILR

Other: Device Implantation - A prospective, blocked, randomised, placebo-controlled trial of primary prophylaxis ICD therapy or implantable loop recorder (ILR) insertion in patients with LVEF 36-50% and Late Gadolinium Enhancement(LGE)on CMR

No Intervention: Observational Registry - A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR


Treatment: Devices: ICD


Treatment: Devices: ILR
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia
Timepoint [1] 0 0
Through to study completion, an average of 4 years
Secondary outcome [1] 0 0
Sudden Cardiac Death
Timepoint [1] 0 0
Through to study completion, an average of 4 years
Secondary outcome [2] 0 0
Haemodynamically significant ventricular arrhythmia
Timepoint [2] 0 0
Through to study completion, an average of 4 years
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
Through to study completion, an average of 4 years
Secondary outcome [4] 0 0
Change in New York Heart Association Functional class
Timepoint [4] 0 0
3, 6,12, 24, 36, 48 months
Secondary outcome [5] 0 0
Heart failure related hospitalizations
Timepoint [5] 0 0
Through to study completion, an average of 4 years
Secondary outcome [6] 0 0
Health economic evaluation of cost
Timepoint [6] 0 0
At study completion, average of 4 years
Secondary outcome [7] 0 0
Quality of life assessed by Minnesota Living with Heart Failure Questionnaire
Timepoint [7] 0 0
3, 6,12, 24, 36, 48 months
Secondary outcome [8] 0 0
Quality of life assessed by EuroQol-5D-5L questionnaire
Timepoint [8] 0 0
3, 6,12, 24, 36, 48 months

Eligibility
Key inclusion criteria
- Age equal or greater than 18 years

- Patients with coronary artery disease (CAD) or dilated cardiomyopathy (DCM) of the
idiopathic, chronic post myocarditis or familial type.

- Left ventricular systolic impairment as defined by left ventricular ejection fraction
36-50% by any current standard technique (echocardiogram, multiple gated acquisition
scan (MUGA), angiography or CMR taken in the last six months. If a LGE CMR has been
taken within 2 months this scan can be used for inclusion

- Able and willing to comply with all pre-, post- and follow-up testing, and
requirements

- On maximum tolerated doses of ACE inhibitors (or Angiotensin and Receptor Blockers if
intolerant of ACE) and Beta Blockers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of cardiac arrest or spontaneous or inducible sustained ventricular
tachycardia or ventricular fibrillation unless within 48 hours of an acute MI

2. Cardiomyopathy related to sarcoidosis

3. Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe
claustrophobia)

4. Currently implanted permanent pacemaker and/or pacemaker/ICD lead

5. Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy.

6. CMR LVEF =35% or>50%

7. Severe renal insufficiency (eGFR< 30mls/min/1.73m2)

8. Recent Myocardial Infarction (MI) (<40 days) or cardiac revascularization (<90 days)

9. New York Heart Association HF functional class IV at baseline

10. Conditions associated with life expectancy <1 year

11. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of
contraception

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
449
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [6] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [7] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [8] 0 0
The Alfred - Melbourne
Recruitment hospital [9] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [10] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [6] 0 0
7000 - Hobart
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment postcode(s) [10] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Coburg
Country [2] 0 0
Germany
State/province [2] 0 0
Villingen-Schwenningen
Country [3] 0 0
Germany
State/province [3] 0 0
Wurzburg
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Belfast
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Bristol
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Clydebank
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Leicester
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Other
Name
Flinders University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Australian Health and Medical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Contemporary heart failure (HF) guidelines recommend insertion of a primary prevention
implantable defibrillator (ICD) in patients with left ventricular ejection fraction less than
35% (LVEF < 35%) on maximally tolerated medical therapy. Nevertheless, there are a
substantial number of HF patients who have LVEF>35% and hence do not qualify for ICD, who
succumb to sudden cardiac death (SCD). At present our tools to reliably risk stratify these
patients with mild-moderate systolic dysfunction (LVEF 36-50%) are poor. It is likely that
these patients have ventricular scar and/or replacement fibrosis as a substrate for their
malignant arrhythmia. Cardiovascular magnetic resonance imaging (CMR) can reliably identify
and quantify both ventricular scar (seen in Ischaemic cardiomyopathy, ICM) and replacement
myocardial fibrosis (seen in Non-Ischemic Cardiomyopathy, NICM).

Methods/Design: A multi-centre randomised controlled trial in which 428 patients with
mild-moderate left-ventricular systolic dysfunction (either ICM or NICM) and ventricular
scar/fibrosis on cardiovascular magnetic resonance are randomized to either ICD or
implantable loop recorder (ILR) insertion and are followed up until the last patient
recruited has been in the study for 3 years.

Potentially eligible patients will have a screening CMR and will be enrolled into the device
arm of study based on the presence of any ventricular scar/fibrosis (CMR +). Patients who do
not have ventricular scar/fibrosis will be followed up in an observational registry, and will
not be randomised.

In both the device and registry arms, we aim to enrol 700 patients in Australia and 355 in
Europe.

The primary hypothesis is that among patients with mild-moderate left ventricular systolic
dysfunction, a routine CMR guided management strategy of ICD insertion is superior to a
conservative strategy of standard care.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01918215
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph B Selvanayagam, MBBS
Address 0 0
Flinders Medical Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01918215