Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - NIDCM (idiopathic or familial)\* - LVEF ≤35% and presence of fibrosis on CMR - Diagnostic CMR scan - Age ≥18 years - Written willing to sign a consent form - Ability to give willing to sign a consent form Who Should NOT Join This Trial: - 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 willing to sign a consent form - Participation in another randomized trial - Life expectancy \<2 years Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

ICD/CRT-D implantation

ICD/CRT-D implantation (if indicated)

Locations (1)

Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany