Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03993730
Study type Interventional
Source Flinders University
Contact Joseph B Selvanayagam, MBBS
Phone +61 8 8404 2195
Email joseph.selvanayagam@flinders.edu.au
Status Not yet recruiting
Phase N/A
Start date June 2020
Completion date June 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Not yet recruiting NCT04703751 - Evaluation of the CIRCULATE Catheter for Transcoronary Administration of Pharmacologic and Cell-based Agents N/A
Recruiting NCT01157299 - Hemodynamic Evaluation of Preload Responsiveness in Children by Using PiCCO N/A
Completed NCT00765518 - Use of Ixmyelocel-T (Formerly Cardiac Repair Cell [CRC] Treatment) in Patients With Heart Failure Due to Dilated Cardiomyopathy (IMPACT-DCM) Phase 2
Completed NCT02115581 - Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy Phase 4
Recruiting NCT04246450 - Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy N/A
Recruiting NCT05799833 - Low QRS Voltages in Young Healthy Individuals and Athletes
Recruiting NCT01914081 - Resveratrol: A Potential Anti- Remodeling Agent in Heart Failure, From Bench to Bedside Phase 3
Recruiting NCT02915718 - A Clinical Study of Immunoadsorption Therapy for Dilated Cardiomyopathy N/A
Recruiting NCT03061994 - Metabolomic Study of All-age Cardiomyopathy N/A
Completed NCT03893760 - Assessment of Right Ventricular Function in Advanced Heart Failure
Not yet recruiting NCT01219452 - Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy Phase 1/Phase 2
Recruiting NCT02175836 - Arrhythmia Prediction Trial N/A
Active, not recruiting NCT00962364 - Long-term Evaluation of Patients Receiving Bone Marrow-derived Cell Administration for Heart Disease
Recruiting NCT05026112 - The Arrhythmogenic Potential of Midwall Septal Fibrosis in Dilated Cardiomyopathy
Recruiting NCT05237323 - Micophenolate Mofetil Versus Azathioprine in Myocarditis Phase 3
Recruiting NCT04649034 - Intraventricular Stasis In Cardiovascular Disease
Suspended NCT03071653 - Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study Phase 2
Completed NCT02619825 - Non-Invasive Evaluation of Myocardial Stiffness by Elastography in Pediatric Cardiology (Elasto-Pédiatrie) N/A