Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Study Overview
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Brief Summary
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Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.

Detailed Description
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The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.

Official Title
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Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Conditions
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Non-ischemic Dilated Cardiomyopathy

Intervention / Treatment
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* Other: ICD/CRT-D implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NIDCM (idiopathic or familial)* LVEF ≤35% and presence of fibrosis on CMR Diagnostic CMR scan Age ≥18 years Written informed consent Ability to give informed consent Exclusion Criteria: ICM [previous myocardial infarction, previous percutaneous coronary intervention] Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy]. Myocarditis Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium) Severe renal insufficiency (creatinine clearance <30 mL/min) Current pacemaker or defibrillator in situ Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD) Renal impairment defined as an eGFR <30 milliliters Age <18 years Patients presenting with pregnancy Patients without informed consent Participation in another randomized trial Life expectancy <2 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICD group<br>Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated. | Other: ICD/CRT-D implantation<br>* ICD/CRT-D implantation (if indicated)<br>|
| No Intervention: Optimal HF care group<br>Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause | Death from any causes during follow-up - after discharge. | Day 0 |