💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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