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Trial record 45 of 157 for:    Idiopathic Dilated Cardiomyopathy

Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy (CMR GUIDE DCM)

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ClinicalTrials.gov Identifier: NCT03993730
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph Selvanayagam, Flinders University

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.


Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Left Ventricular Systolic Dysfunction Fibrosis Myocardial Device: ICD Device: ILR Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2026


Arm Intervention/treatment
Device Implantation
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
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.

No Intervention: Observational Registry
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.



Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: Through to study completion, an average of 4 years ]

Secondary Outcome Measures :
  1. Number of Participants who have Sudden Cardiac Death [ Time Frame: Through to study completion, an average of 4 years ]
  2. Number of Participants who have a Haemodynamically significant ventricular arrhythmia event [ Time Frame: Through to study completion, an average of 4 years ]
  3. Quality of life assessed by Kansas City Cardiomyopathy Questionnaire [ Time Frame: Measured at 3, 6, 12, 24, 36 months through to study completion ]
    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the above 23 items which will be between 0-100. A higher score reflects a better health status.

  4. Number of Participants who have a Heart Failure related hospitalisation [ Time Frame: Through to study completion, an average of 4 years ]
  5. Health economic evaluation of cost [ Time Frame: At study completion, an average of 4 years ]
    Various different country jurisdictions will be chosen



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03993730


Contacts
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Contact: Joseph B Selvanayagam, MBBS +61 8 8404 2195 joseph.selvanayagam@flinders.edu.au

Sponsors and Collaborators
Flinders University
Investigators
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Principal Investigator: Joseph B Selvanayagam, MBBS Flinders Medical Centre

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Responsible Party: Joseph Selvanayagam, Principal Investigator, Flinders University
ClinicalTrials.gov Identifier: NCT03993730     History of Changes
Other Study ID Numbers: CMRG-2
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly