Back to resultsCardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy (CMR GUIDE DCM)
Primary Purpose
Dilated Cardiomyopathy, Left Ventricular Systolic Dysfunction, Fibrosis Myocardial
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICD
ILR
Sponsored by
About this trial
This is an interventional prevention trial for Dilated Cardiomyopathy
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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Device Implantation
Observational Registry
Arm Description
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
Outcomes
Primary Outcome Measures
All-Cause Mortality
Secondary Outcome Measures
Number of Participants who have Sudden Cardiac Death
Number of Participants who have a Haemodynamically significant ventricular arrhythmia event
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
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
Health economic evaluation of cost
Various different country jurisdictions will be chosen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03993730
Brief Title
Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Acronym
CMR GUIDE DCM
Official Title
Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Flinders University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy, Left Ventricular Systolic Dysfunction, Fibrosis Myocardial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1880 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Device Implantation
Arm Type
Other
Arm Description
A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR.
Arm Title
Observational Registry
Arm Type
No Intervention
Arm Description
A prospective observational registry of patients with LVEF <45% and no LGE on CMR.
Intervention Type
Device
Intervention Name(s)
ICD
Intervention Description
Insertion of ICD in patients with LVEF <45% and LGE on CMR.
Intervention Type
Device
Intervention Name(s)
ILR
Intervention Description
Insertion of ILR in patients with LVEF <45% and LGE on CMR.
Primary Outcome Measure Information:
Title
All-Cause Mortality
Time Frame
Through to study completion, an average of 4 years
Secondary Outcome Measure Information:
Title
Number of Participants who have Sudden Cardiac Death
Time Frame
Through to study completion, an average of 4 years
Title
Number of Participants who have a Haemodynamically significant ventricular arrhythmia event
Time Frame
Through to study completion, an average of 4 years
Title
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
Description
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.
Time Frame
Measured at 3, 6, 12, 24, 36 months through to study completion
Title
Number of Participants who have a Heart Failure related hospitalisation
Time Frame
Through to study completion, an average of 4 years
Title
Health economic evaluation of cost
Description
Various different country jurisdictions will be chosen
Time Frame
At study completion, an average of 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph B Selvanayagam, MBBS
Phone
+61 8 8404 2195
Email
joseph.selvanayagam@flinders.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph B Selvanayagam, MBBS
Organizational Affiliation
Flinders Medical Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
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