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CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.
Patients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).
954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).
Device and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.
The planned research will have two components: A prospective, blocked, randomized, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and Late Gadolinium Enhancement (LGE) on CMR and
A prospective observational registry of patients with LVEF <45% and no LGE on CMR. Registry patients will not have an intervention but will have the same follow up frequency as the randomized patients.
The Primary objective is to determine if routine CMR guided management strategy of implantable defibrillator (ICD) insertion reduces total mortality compared to a conservative strategy of implantable loop recorder (ILR) insertion and standard care.
The secondary objectives include:
Statistical analysis will be performed on an intention-to-treat basis. The main analysis of time to death from any cause will be performed using a log- rank test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Implantation | Other | A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR. |
|
| Observational Registry | No Intervention | A prospective observational registry of patients with LVEF <45% and no LGE on CMR. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICD | Device | Insertion of ICD in patients with LVEF <45% and LGE on CMR. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality | Through to study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who have Sudden Cardiac Death | Through to study completion, an average of 4 years | |
| Number of Participants who have a Haemodynamically significant ventricular arrhythmia event | Through to study completion, an average of 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joseph B Selvanayagam, MBBS | Contact | +61 8 8404 2195 | joseph.selvanayagam@flinders.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Joseph B Selvanayagam, MBBS | Flinders Medical Centre | Principal Investigator |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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| ILR |
| Device |
Insertion of ILR in patients with LVEF <45% and LGE on CMR. |
|
| Quality of life assessed by Kansas City Cardiomyopathy Questionnaire | The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the above 23 items which will be between 0-100. A higher score reflects a better health status. | Measured at 3, 6, 12, 24, 36 months through to study completion |
| Number of Participants who have a Heart Failure related hospitalisation | Through to study completion, an average of 4 years |
| Health economic evaluation of cost | Various different country jurisdictions will be chosen | At study completion, an average of 4 years |
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D018754 | Ventricular Dysfunction |