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

Non-ischemic Dilated Cardiomyopathy Clinical Trial

— CMR-ICD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04558723
• Other study ID #: 20-275
• Secondary ID: CMR-ICD-DZHK23
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: November 2025

Study information

• Verified date: May 2022
• Source: University of Luebeck
• Contact: Ingo Eitel, Prof. Dr.
• Phone: +49 451 500 44501
• Email: ingo.eitel[@]uksh.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: November 2025
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Non-ischemic Dilated Cardiomyopathy

Intervention

Other:
• ICD/CRT-D implantation
ICD/CRT-D implantation (if indicated)

Locations

Country	Name	City	State
Germany	Universität zu Lübeck	Lübeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. med. Ingo Eitel	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause	Death from any causes during follow-up - after discharge.	Day 0