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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf. Dr. med. Ingo Eitel

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ICD/CRT-D implantation

    Other intervention

    ICD/CRT-D implantation (if indicated)

Treatment groups

760 Participants
are divided into 2 treatment groups
Group A: ICD groupExperimental treatment 1 intervention
Group B: Optimal HF care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Death from any cause

Death from any causes during follow-up - after discharge.

Time frame
Day 0

Secondary outcomes

Other outcomes

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