Using cardiac imaging to guide defibrillator implantation in heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.