Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICD/CRT-D implantation.
- Who it may be relevant to
- Registry conditions: Non-ischemic Dilated Cardiomyopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Overview
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.
Interventions
- Other ICD/CRT-D implantation
ICD/CRT-D implantation (if indicated)
Primary outcome measures
- Death from any cause [Time frame: Day 0]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Universität zu Lübeck — Lübeck
Identifiers
NCT: NCT04558723 · 20-275 · CMR-ICD-DZHK23