Dilated CardiomyopathyCMR GUIDE DCMNCT03993730
Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
A study testing ICD and ILR in people with Dilated Cardiomyopathy and Left Ventricular Systolic Dysfunction, run by Flinders University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy, Left Ventricular Systolic Dysfunction, Fibrosis Myocardial
- What is being tested?
- ICD and ILR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,880 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- ICD, ILR
- Medical subject headings
- Cardiomyopathy, Dilated, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICDDevice
Insertion of ICD in patients with LVEF <45% and LGE on CMR.
ILRDevice
Insertion of ILR in patients with LVEF <45% and LGE on CMR.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ICD; Device: ILR |
| Observational Registry | No intervention | A prospective observational registry of patients with LVEF <45% and no LGE on CMR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Measured: Through to study completion, an average of 4 years
Secondary outcomes (5)
Number of Participants who have Sudden Cardiac Death
Measured: Through to study completion, an average of 4 years
Number of Participants who have a Haemodynamically significant ventricular arrhythmia event
Measured: Through to study completion, an average of 4 years
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.
Measured: Measured at 3, 6, 12, 24, 36 months through to study completion
Number of Participants who have a Heart Failure related hospitalisation
Measured: Through to study completion, an average of 4 years
Health economic evaluation of cost
Various different country jurisdictions will be chosen
Measured: At study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study startJun 2020 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Flinders University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Selvanayagam, Flinders University
- Investigators
- Joseph B Selvanayagam, MBBS, Principal investigator, Flinders Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993730
- Sponsor's protocol ID
- CMRG-2
- Acronym
- CMR GUIDE DCM
- Status last verified
- Jun 2019
- First submitted
- 3 May 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy
- ClinicalTrials.gov ID
- NCT03993730
- Acronym / sponsor ID
- CMR GUIDE DCM / CMRG-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,880 participants (estimated)
- Lead sponsor
- Flinders UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Implantation | Other | Device: ICD, Device: ILRA prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF <45% and LGE on CMR. |
| Observational Registry | No intervention | –A prospective observational registry of patients with LVEF <45% and no LGE on CMR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICDInsertion of ICD in patients with LVEF <45% and LGE on CMR. | Device | Device Implantation |
| ILRInsertion of ILR in patients with LVEF <45% and LGE on CMR. | Device | Device Implantation |
Primary outcome
All-Cause Mortality
Time frame: Through to study completion, an average of 4 years
5 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph B Selvanayagam, MBBS principal investigator
Flinders Medical Centre
Questions about this trial
What is this clinical trial studying?
A study testing ICD and ILR in people with Dilated Cardiomyopathy and Left Ventricular Systolic Dysfunction, run by Flinders University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph B Selvanayagam, MBBS (+61 8 8404 2195, joseph.selvanayagam@flinders.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: Through to study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.