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

NCT04558723 | Recruiting DMC

• 2 other identifiers: 20-275CMR-ICD-DZHK23
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-ischemic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Death from any cause

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

  Day 0

Study Arms (2)

ICD group

EXPERIMENTAL

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

Other: ICD/CRT-D implantation

Optimal HF care group

NO INTERVENTION

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.

Interventions

ICD/CRT-D implantation OTHER

ICD/CRT-D implantation (if indicated)

ICD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Study Officials

• Ingo Eitel, Prof. Dr.

  Medical Clinic II - University Heart Center Lübeck

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingo Eitel, Prof. Dr.

CONTACT

+49 451 500 44501; ingo.eitel@uksh.de

Thomas Stiermaier, Dr.

CONTACT

+49 451 500 44501; thomas.stiermaier@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: January 14, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

DE (1)