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.
Condition or disease | Intervention/treatment | Phase |
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Dilated Cardiomyopathy Left Ventricular Systolic Dysfunction Fibrosis Myocardial | Device: ICD Device: ILR | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1880 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy |
Estimated Study Start Date : | June 2020 |
Estimated Primary Completion Date : | June 2026 |
Estimated Study Completion Date : | June 2026 |
Arm | Intervention/treatment |
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Device Implantation
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
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Device: ICD
Insertion of ICD in patients with LVEF <45% and LGE on CMR.
Device: ILR Insertion of ILR in patients with LVEF <45% and LGE on CMR.
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No Intervention: Observational Registry
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joseph B Selvanayagam, MBBS | +61 8 8404 2195 | joseph.selvanayagam@flinders.edu.au |
Principal Investigator: | Joseph B Selvanayagam, MBBS | Flinders Medical Centre |
Tracking Information | |||||
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First Submitted Date ICMJE | May 3, 2019 | ||||
First Posted Date ICMJE | June 21, 2019 | ||||
Last Update Posted Date | June 21, 2019 | ||||
Estimated Study Start Date ICMJE | June 2020 | ||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
All-Cause Mortality [ Time Frame: Through to study completion, an average of 4 years ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy | ||||
Official Title ICMJE | Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy | ||||
Brief Summary |
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. |
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Detailed Description |
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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
1880 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | June 2026 | ||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03993730 | ||||
Other Study ID Numbers ICMJE | CMRG-2 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Joseph Selvanayagam, Flinders University | ||||
Study Sponsor ICMJE | Flinders University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Flinders University | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |