Actively Recruiting
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Led by Prof. Dr. med. Ingo Eitel · Updated on 2024-05-13
760
Participants Needed
1
Research Sites
354 weeks
Total Duration
On this page
Sponsors
P
Prof. Dr. med. Ingo Eitel
Lead Sponsor
D
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-ischemic dilated cardiomyopathy (NIDCM), idiopathic or familial
- Left ventricular ejection fraction (LVEF) 35% or less with fibrosis present on cardiac magnetic resonance (CMR)
- Diagnostic CMR scan available
- Age 18 years or older
- Written informed consent provided
- Ability to give informed consent
You will not qualify if you...
- Ischemic cardiomyopathy (previous heart attack or coronary intervention)
- Other types of cardiomyopathy including hypertrophic, arrhythmogenic right ventricular, restrictive, infiltrative (e.g., amyloidosis, sarcoidosis, hemochromatosis), left ventricular non-compaction, or reversible cardiomyopathies (Takotsubo syndrome, peripartum, chemotherapy-induced)
- Myocarditis
- Contraindications for CMR (severe claustrophobia, pacemaker or ICD, metallic brain implants, gadolinium allergy)
- Severe kidney impairment (creatinine clearance less than 30 mL/min or eGFR below 30 mL/min)
- Current pacemaker or defibrillator in place
- Indication for device therapy such as secondary prevention after aborted sudden cardiac death
- Age under 18 years
- Pregnancy
- Lack of informed consent
- Participation in another randomized trial
- Life expectancy less than 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universität zu Lübeck
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
Research Team
I
Ingo Eitel, Prof. Dr.
CONTACT
T
Thomas Stiermaier, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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