NCT03993730

Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,880 (estimated)
• Sponsor: Flinders University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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: * 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.

Conditions

• Dilated Cardiomyopathy
• Left Ventricular Systolic Dysfunction
• Fibrosis Myocardial

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-06-21
• Last updated: 2019-06-21