Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction. (CMR_GUIDE)
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|ClinicalTrials.gov Identifier: NCT01918215|
Recruitment Status : Recruiting
First Posted : August 7, 2013
Last Update Posted : April 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Left Ventricular Systolic Dysfunction||Device: ICD Device: ILR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1055 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction|
|Actual Study Start Date :||July 2015|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||August 2023|
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
No Intervention: Observational Registry
A prospective observational registry of patients with LVEF 36-50% and no LGE on CMR
- Composite of Sudden Cardiac Death or haemodynamically significant ventricular arrhythmia [ Time Frame: Through to study completion, an average of 4 years ]Defined as: ventricular arrhythmia producing syncope (loss of consciousness) or associated with hypotension (SBP<90mmHg) except directly associated with device implant procedure.
- Sudden Cardiac Death [ Time Frame: Through to study completion, an average of 4 years ]
- Haemodynamically significant ventricular arrhythmia [ Time Frame: Through to study completion, an average of 4 years ]
- All-cause mortality [ Time Frame: Through to study completion, an average of 4 years ]
- Change in New York Heart Association Functional class [ Time Frame: 3, 6,12, 24, 36, 48 months ]
- Heart failure related hospitalizations [ Time Frame: Through to study completion, an average of 4 years ]
- Health economic evaluation of cost [ Time Frame: At study completion, average of 4 years ]Australia only
- Quality of life assessed by Minnesota Living with Heart Failure Questionnaire [ Time Frame: 3, 6,12, 24, 36, 48 months ]
- Quality of life assessed by EuroQol-5D-5L questionnaire [ Time Frame: 3, 6,12, 24, 36, 48 months ]
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): NCT01918215
|Contact: Joseph B Selvanayagam, MBBS||+61 8 8404 email@example.com|
|Principal Investigator:||Joseph B Selvanayagam, MBBS||Flinders Medical Centre|