Heart FailureCMR_GUIDENCT01918215
Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction.
A study testing ICD and ILR in people with Heart Failure and Left Ventricular Systolic Dysfunction, run by Flinders University at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left Ventricular Systolic Dysfunction
- What is being tested?
- ICD and ILR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 453 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Jul 2015to 12 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of cardiac arrest or spontaneous or inducible sustained ventricular tachycardia or ventricular fibrillation unless within 48 hours of an acute MI
- Cardiomyopathy related to sarcoidosis
- Standard Cardiac Magnetic Resonance imaging contraindications (e.g. severe claustrophobia)
- Currently implanted permanent pacemaker and/or pacemaker/ICD lead
- Clinical indication for ICD or Pacemaker or cardiac resynchronisation therapy.
- CMR LVEF ≤35% or>50%
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- Severe renal insufficiency (eGFR< 30mls/min/1.73m2)
- Recent Myocardial Infarction (MI) (<40 days) or cardiac revascularization (<90 days)
- New York Heart Association HF functional class IV at baseline
- Conditions associated with life expectancy <1 year
- Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
Australia10 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
St Vincent's Hospital
Fitzroy, Victoria, 3065
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 7000
The Alfred
Melbourne, Victoria, 3004
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
John Hunter Hospital
New Lambton, New South Wales, 2305
Royal Perth Hospital
Perth, Western Australia, 6000
United Kingdom5 sites
Belfast Health and Social Care Trust
Belfast, BT12 6NT
The Bristol Heart Institute
Bristol, BS2 8HW
Golden Jubilee National Hospital
Clydebank, G814DY
Glenfield General Hospital
Leicester, LE39QP
University Hospital of South Manchester NHS Foundation Trust
Manchester, M23 9LT
Germany3 sites
Coburg Hospital
Coburg, 96450
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78052
University Hospital Wurzburg
Würzburg, 97080
About this study
Official title: Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction
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.
Read more
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.
- Being tested
- ICD, ILR
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
ILRDevice
| Study group | Role | What they receive |
|---|---|---|
| Device Implantation | Other | 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 Receives: Device: ICD; Device: ILR |
| Observational Registry | No intervention | A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia
Defined as: ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP<90mmHg) except directly associated with device implant procedure.
Measured: Through to study completion, an average of 4 years
Secondary outcomes (8)
Sudden Cardiac Death
Measured: Through to study completion, an average of 4 years
Haemodynamically significant ventricular arrhythmia
Measured: Through to study completion, an average of 4 years
All-cause mortality
Measured: Through to study completion, an average of 4 years
Change in New York Heart Association Functional class
Measured: 3, 6,12, 24, 36, 48 months
Heart failure related hospitalizations
Measured: Through to study completion, an average of 4 years
Health economic evaluation of cost
Australia only
Measured: At study completion, average of 4 years
Quality of life assessed by Minnesota Living with Heart Failure Questionnaire
Measured: 3, 6,12, 24, 36, 48 months
Quality of life assessed by EuroQol-5D-5L questionnaire
Measured: 3, 6,12, 24, 36, 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startJul 2015
- Primary completionApr 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flinders University
- Sponsor type
- University, hospital or other
- Collaborators
- South Australian Health and Medical Research Institute
- Responsible party
- Principal investigator, Joseph Selvanayagam, Flinders University
- Investigators
- Joseph B Selvanayagam, MBBS, Principal investigator, Flinders Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918215
- Sponsor's protocol ID
- CMRG-HF-1
- Acronym
- CMR_GUIDE
- Status last verified
- Jul 2026
- First submitted
- 19 Apr 2013
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Selvanayagam JB, Cleland JGF, Hillis GS, Pasupathy S, Billot L, George KE, Atherton JJ, Berry C, Tonchev I, Gianacas C, Jung W, Prasad SK, De Pasquale CG, Brachmann J, Ganesan A; Cardiovascular Magnetic Resonance-Guided Management of Mild to Moderate Left Ventricular Systolic Dysfunction Trial Investigators. Cardiovascular Magnetic Resonance to Guide Defibrillator Implantation for LVEF of 36% to 50%: The CMR GUIDE Randomized Clinical Trial. JAMA. 2026 Aug 28:e2617078. doi: 10.1001/jama.2026.17078. Online ahead of print.
PubMed 42663169Selvanayagam JB, Hartshorne T, Billot L, Grover S, Hillis GS, Jung W, Krum H, Prasad S, McGavigan AD. Cardiovascular magnetic resonance-GUIDEd management of mild to moderate left ventricular systolic dysfunction (CMR GUIDE): Study protocol for a randomized controlled trial. Ann Noninvasive Electrocardiol. 2017 Jul;22(4):e12420. doi: 10.1111/anec.12420. Epub 2017 Jan 24.
PubMed 28117536