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

Sponsor
Prof. Dr. med. Ingo Eitel (Other)
Overall Status
Recruiting
CT.gov ID
NCT04558723
Collaborator
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other)
760
Enrollment
1
Location
2
Arms
57.6
Anticipated Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: ICD/CRT-D implantation
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
760 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Actual Study Start Date :
Jan 14, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICD group

Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated.

Other: ICD/CRT-D implantation
ICD/CRT-D implantation (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.

Outcome Measures

Primary Outcome Measures

  1. Death from any cause [Day 0]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universität zu Lübeck Lübeck Schleswig-Holstein Germany 23538

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Ingo Eitel, Prof. Dr., Medical Clinic II - University Heart Center Lübeck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Dr. med. Ingo Eitel, Director, University of Luebeck
ClinicalTrials.gov Identifier:
NCT04558723
Other Study ID Numbers:
  • 20-275
  • CMR-ICD-DZHK23
First Posted:
Sep 22, 2020
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated

Study Results

No Results Posted as of May 24, 2022