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

NCT03993730 | Not Yet Recruiting DMC

• 1 other identifier: CMRG-2
• Study Type: interventional
• Target: 1,880
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dilated Cardiomyopathy; Left Ventricular Systolic Dysfunction; Fibrosis Myocardial

Outcome Measures

Primary Outcomes (1)

• All-Cause Mortality

  Through to study completion, an average of 4 years

Secondary Outcomes (5)

• Number of Participants who have Sudden Cardiac Death

  Through to study completion, an average of 4 years

• Number of Participants who have a Haemodynamically significant ventricular arrhythmia event

  Through to study completion, an average of 4 years

• Quality of life assessed by Kansas City Cardiomyopathy Questionnaire

  Measured at 3, 6, 12, 24, 36 months through to study completion

• Number of Participants who have a Heart Failure related hospitalisation

  Through to study completion, an average of 4 years

• Health economic evaluation of cost

  At study completion, an average of 4 years

Study Arms (2)

Device Implantation

OTHER

A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF \<45% and LGE on CMR.

Device: ICD; Device: ILR

Observational Registry

NO INTERVENTION

A prospective observational registry of patients with LVEF \<45% and no LGE on CMR.

Interventions

ICD DEVICE

Insertion of ICD in patients with LVEF \<45% and LGE on CMR.

Device Implantation

ILR DEVICE

Insertion of ILR in patients with LVEF \<45% and LGE on CMR.

Device Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than/equal to 18 years old
• Non-ischemic cardiomyopathy of dilated type
• Left Ventricular Ejection Fraction \< 45%
• Able and willing to comply with all pre, post and follow-up testing and requirements
• On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers

You may not qualify if:

• Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)
• Hypertrophic Cardiomyopathy
• Cardiomyopathy related to sarcoidosis
• Arrhythmogenic Right Ventricular Dysplasia
• Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)
• Currently implanted permanent pacemaker and/or pacemaker/ICD lead
• Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy
• Contraindications to intravenous Gadolinium
• Severe renal insufficiency (eGFR\< 45mls/min/1.73m2 )
• New York Heart Association Heart Failure functional class IV
• Conditions associated with life expectancy \<1 year
• Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception

Sponsors & Collaborators

• Flinders University: lead

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ventricular Dysfunction

Study Officials

• Joseph B Selvanayagam, MBBS

  Flinders Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph B Selvanayagam, MBBS

CONTACT

+61 8 8404 2195; joseph.selvanayagam@flinders.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: June 21, 2019
• Study Start: June 1, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share