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出境医 / 临床实验 / Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy (CMR GUIDE DCM)

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

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

Sponsors and Collaborators
Flinders University
Investigators
Layout table for investigator information
Principal Investigator: Joseph B Selvanayagam, MBBS Flinders Medical Centre
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
All-Cause Mortality [ Time Frame: Through to study completion, an average of 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Number of Participants who have Sudden Cardiac Death [ Time Frame: Through to study completion, an average of 4 years ]
  • Number of Participants who have a Haemodynamically significant ventricular arrhythmia event [ Time Frame: Through to study completion, an average of 4 years ]
  • 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.
  • Number of Participants who have a Heart Failure related hospitalisation [ Time Frame: Through to study completion, an average of 4 years ]
  • Health economic evaluation of cost [ Time Frame: At study completion, an average of 4 years ]
    Various different country jurisdictions will be chosen
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dilated Cardiomyopathy
  • Left Ventricular Systolic Dysfunction
  • Fibrosis Myocardial
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: ICD
    • Device: ILR
  • No Intervention: Observational Registry
    A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019)
1880
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2026
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joseph B Selvanayagam, MBBS +61 8 8404 2195 joseph.selvanayagam@flinders.edu.au
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993730
Other Study ID Numbers  ICMJE CMRG-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Joseph Selvanayagam, Flinders University
Study Sponsor  ICMJE Flinders University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph B Selvanayagam, MBBS Flinders Medical Centre
PRS Account Flinders University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP