RecruitingNot ApplicableNCT04558723
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
Sponsor
Prof. Dr. med. Ingo Eitel
Enrollment
760 participants
Start Date
Jan 14, 2021
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria13
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
OTHERICD/CRT-D implantation
ICD/CRT-D implantation (if indicated)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04558723
Related Trials
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
NCT044769014 locations
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
NCT057690361 location
Left Bundle Branch Pacing on Outcomes and Ventricular Remodeling in Biventricular CRT Nonresponders
NCT057609241 location
Study of Personalized Allocation of Defibrillators in Non-ischemic Heart Failure (SPANISH-1)
NCT0605550431 locations