About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
NIDCM (idiopathic or familial)*
LVEF ≤35% and presence of fibrosis on CMR
Diagnostic CMR scan
Age ≥18 years
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
ICD/CRT-D implantation
Other interventionICD/CRT-D implantation (if indicated)
Treatment groups
Trial outcomes
Primary outcomes
Death from any cause
Death from any causes during follow-up - after discharge.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof. Dr. med. Ingo Eitel
Lead sponsor
University of Luebeck
Sponsor institution
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborator