NCT04558723

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Prof. Dr. med. Ingo Eitel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Non-ischemic Dilated Cardiomyopathy

Interventions

Type	Name	Description
OTHER	ICD/CRT-D implantation	ICD/CRT-D implantation (if indicated)

Timeline

• Start date: 2021-01-14
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2020-09-22
• Last updated: 2024-05-13

Locations

1 site across 1 country: Germany