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| Name | Class |
|---|---|
| South Australian Health and Medical Research Institute | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Observational Registry | No Intervention | A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD | Device |
| ||
| ILR |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through to study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sudden Cardiac Death | Through to study completion, an average of 4 years | |
| Haemodynamically significant ventricular arrhythmia | Through to study completion, an average of 4 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph B Selvanayagam, MBBS | Flinders Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunter Hospital | New Lambton | New South Wales | 2305 | Australia | ||
| Princess Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28117536 | Derived | Selvanayagam 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. |
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|
| All-cause mortality |
| Through to study completion, an average of 4 years |
| Change in New York Heart Association Functional class | 3, 6,12, 24, 36, 48 months |
| Heart failure related hospitalizations | Through to study completion, an average of 4 years |
| Health economic evaluation of cost | Australia only | At study completion, average of 4 years |
| Quality of life assessed by Minnesota Living with Heart Failure Questionnaire | 3, 6,12, 24, 36, 48 months |
| Quality of life assessed by EuroQol-5D-5L questionnaire | 3, 6,12, 24, 36, 48 months |
| Brisbane |
| Queensland |
| 4102 |
| Australia |
| Royal Brisbane & Women's Hospital | Herston | Queensland | 4029 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Lyell McEwin Hospital | Elizabeth Vale | South Australia | 5112 | Australia |
| Royal Hobart Hospital | Hobart | Tasmania | 7000 | Australia |
| St Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Coburg Hospital | Coburg | 96450 | Germany |
| Schwarzwald-Baar Klinikum | Villingen-Schwenningen | 78052 | Germany |
| University Hospital Wurzburg | Würzburg | 97080 | Germany |
| Belfast Health and Social Care Trust | Belfast | BT12 6NT | United Kingdom |
| The Bristol Heart Institute | Bristol | BS2 8HW | United Kingdom |
| Golden Jubilee National Hospital | Clydebank | G814DY | United Kingdom |
| Glenfield General Hospital | Leicester | LE39QP | United Kingdom |
| University Hospital of South Manchester NHS Foundation Trust | Manchester | M23 9LT | United Kingdom |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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