NCT04558723 Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
| NCT ID | NCT04558723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Dr. med. Ingo Eitel |
| Condition | Non-ischemic Dilated Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 760 participants |
| Start Date | 2021-01-14 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 760 participants in total. It began in 2021-01-14 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Ingo Eitel, Prof. Dr.
PRINCIPAL INVESTIGATOR
Medical Clinic II - University Heart Center Lübeck
Frequently Asked Questions
Who can join the NCT04558723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-ischemic Dilated Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04558723 currently recruiting?
Yes, NCT04558723 is actively recruiting participants. Contact the research team at ingo.eitel@uksh.de for enrollment information.
Where is the NCT04558723 trial being conducted?
This trial is being conducted at Lübeck, Germany.
Who is sponsoring the NCT04558723 clinical trial?
NCT04558723 is sponsored by Prof. Dr. med. Ingo Eitel. The principal investigator is Ingo Eitel, Prof. Dr. at Medical Clinic II - University Heart Center Lübeck. The trial plans to enroll 760 participants.