Using cardiac imaging to guide defibrillator implantation in heart failure patients
Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
This study is testing if getting a heart device called an ICD can help people with heart failure and heart damage live longer compared to just receiving standard heart care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 760 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Luebeck Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lübeck, Schleswig-Holstein) |
| Trial ID | NCT04558723 on ClinicalTrials.gov |
What this trial studies
This study evaluates whether implantable cardioverter defibrillator (ICD) therapy can reduce the risk of death compared to optimal heart failure care in patients with non-ischemic dilated cardiomyopathy (NIDCM) and significant myocardial fibrosis. Participants will undergo cardiac magnetic resonance (CMR) imaging to assess left ventricular ejection fraction and fibrosis before being randomized into two treatment groups: one receiving ICD implantation and the other receiving optimal heart failure management without ICD. The study aims to provide insights into the effectiveness of ICDs in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with NIDCM, a left ventricular ejection fraction of 35% or less, and evidence of myocardial fibrosis on CMR imaging.
Not a fit: Patients with ischemic cardiomyopathy, other specific types of cardiomyopathies, or contraindications for CMR will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce mortality rates in patients with non-ischemic dilated cardiomyopathy.
How similar studies have performed: Previous studies have shown promising results for ICD therapy in heart failure patients, but this specific approach using CMR guidance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lübeck, Schleswig-Holstein
- Universität zu Lübeck — Lübeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Ingo Eitel, Prof. Dr. — Medical Clinic II - University Heart Center Lübeck
- Study coordinator: Ingo Eitel, Prof. Dr.
- Email: ingo.eitel@uksh.de
- Phone: +49 451 500 44501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.