Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Germany
Universität zu Lübeck
RECRUITING
Lübeck
Contact Information
Primary
Ingo Eitel, Prof. Dr.
ingo.eitel@uksh.de
+49 451 500 44501
Backup
Thomas Stiermaier, Dr.
thomas.stiermaier@uksh.de
+49 451 500 44501
Time Frame
Start Date: 2021-01-14
Estimated Completion Date: 2027-11
Participants
Target number of participants: 760
Treatments
Experimental: ICD group
Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated.
No_intervention: Optimal HF care group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Leads: Prof. Dr. med. Ingo Eitel