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

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Brief Title

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

Official Title

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

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.
    

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.
    


Study Type

Interventional


Primary Outcome

All-Cause Mortality

Secondary Outcome

 Number of Participants who have Sudden Cardiac Death

Condition

Dilated Cardiomyopathy

Intervention

ICD

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

1880

Start Date

June 2020

Completion Date

June 2026

Primary Completion Date

June 2026

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          1. Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant
             Epicardial CAD on Angiography)

          2. Hypertrophic Cardiomyopathy

          3. Cardiomyopathy related to sarcoidosis

          4. Arrhythmogenic Right Ventricular Dysplasia

          5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)

          6. Currently implanted permanent pacemaker and/or pacemaker/ICD lead

          7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy

          8. Contraindications to intravenous Gadolinium

          9. Severe renal insufficiency (eGFR< 45mls/min/1.73m2 )

         10. New York Heart Association Heart Failure functional class IV

         11. Conditions associated with life expectancy <1 year

         12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of
             contraception
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Joseph B Selvanayagam, MBBS, +61 8 8404 2195, [email protected]



Administrative Informations


NCT ID

NCT03993730

Organization ID

CMRG-2


Responsible Party

Principal Investigator

Study Sponsor

Flinders University


Study Sponsor

Joseph B Selvanayagam, MBBS, Principal Investigator, Flinders Medical Centre


Verification Date

June 2019