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

Primary Purpose

Non-ischemic Dilated Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ICD/CRT-D implantation
Sponsored by
Prof. Dr. med. Ingo Eitel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ischemic Dilated Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universität zu LübeckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ICD group

Optimal HF care group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 16, 2020
Last Updated
May 17, 2022
Sponsor
Prof. Dr. med. Ingo Eitel
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
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1. Study Identification

Unique Protocol Identification Number
NCT04558723
Brief Title
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Acronym
CMR-ICD
Official Title
Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. med. Ingo Eitel
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ischemic Dilated Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICD group
Arm Type
Experimental
Arm Description
Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated.
Arm Title
Optimal HF care group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
ICD/CRT-D implantation
Intervention Description
ICD/CRT-D implantation (if indicated)
Primary Outcome Measure Information:
Title
Death from any cause
Description
Death from any causes during follow-up - after discharge.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingo Eitel, Prof. Dr.
Phone
+49 451 500 44501
Email
ingo.eitel@uksh.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Stiermaier, Dr.
Phone
+49 451 500 44501
Email
thomas.stiermaier@uksh.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr.
Organizational Affiliation
Medical Clinic II - University Heart Center Lübeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universität zu Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ingo Eitel, Prof. Dr. med.
First Name & Middle Initial & Last Name & Degree
Thomas Stiermaier, Dr.med

12. IPD Sharing Statement

Learn more about this trial

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

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