Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy (CMR GUIDE DCM)
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|ClinicalTrials.gov Identifier: NCT03993730|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
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|
|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:
- To determine if routine CMR guided management strategy of ICD insertion reduces sudden cardiac death (SCD) compared to a conservative strategy of ILR insertion and standard care.
- To ascertain the rate of SCD in patients with DCM and LGE scar across a wide range of left ventricular ejection fraction (LVEF).
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
Insertion of ICD in patients with LVEF <45% and LGE on CMR.
Insertion of ILR in patients with LVEF <45% and LGE on CMR.
No Intervention: Observational Registry
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
- All-Cause Mortality [ Time Frame: Through to study completion, an average of 4 years ]
- Number of Participants who have Sudden Cardiac Death [ Time Frame: Through to study completion, an average of 4 years ]
- Number of Participants who have a Haemodynamically significant ventricular arrhythmia event [ Time Frame: Through to study completion, an average of 4 years ]
- Quality of life assessed by Kansas City Cardiomyopathy Questionnaire [ Time Frame: Measured at 3, 6, 12, 24, 36 months through to study completion ]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.
- Number of Participants who have a Heart Failure related hospitalisation [ Time Frame: Through to study completion, an average of 4 years ]
- Health economic evaluation of cost [ Time Frame: At study completion, an average of 4 years ]Various different country jurisdictions will be chosen
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993730
|Contact: Joseph B Selvanayagam, MBBS||+61 8 8404 firstname.lastname@example.org|
|Principal Investigator:||Joseph B Selvanayagam, MBBS||Flinders Medical Centre|