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
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