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Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy

Recruitingn/aAges 18 Years - anyAllCentro Medico Teknon
NCT06730464 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Risk stratification for sudden cardiac death (SCD) in patients with non-ischemic cardiomyopathy (NICM) remains suboptimal. Although current guidelines rely on severe left ventricular systolic dysfunction (left ventricular ejection fraction (LVEF) \< 35%) as key predictor of arrhythmic risk and clinical indication of prophylactic implantable cardioverter defibrillator (ICD), this approach seems inadequate, since registries report that only a minority of NICM ICD carriers experience an appropriate ICD shock during follow-up, whereas out-of-hospital cardiac arrests (OHCA) occur in patients with LVEF\>35% in up to 80% of cases. Moreover, pivotal primary prevention trials (DANISH trial, long-term outcome of the SCD-HeFT trial) failed to demonstrate a net mortality benefit of ICD in patients with NICM. As for most structural heart diseases (SHD), scar-related reentry has been addressed as the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of non-ischemic heart disease involving the left ventricle, irrespectively of LVEF. This diagnosis includes: 1. Dilated cardiomyopathy (DCM) 2. Non-dilated left ventricular cardiomyopathy (NDLVC) 3. Post-myocarditis cardiomyopathy * Life expectancy of \> 1 year with a good functional status. * Signed informed consent. * At least one late gadolinium enhancement-cardiac magnetic resonance (LGE-CMR) already performed. * No VA events at the time of the 1st LGE-CMR study. Exclusion Criteria: * Pregnancy. * Life expectancy of \< 1 year, or bad functional status (NYHA IV functional class). * Other concomitant structural heart diseases (e.g. ischemic, congenital, arrhythmogenic right ventricular cardiomyopathy etc.) * No LGE-CMR at time of enrollment or LGE-CMR data not available. * Previously documented sustained ventricular arrhythmias at the time of 1st LGE-CMR. * Concomitant investigation treatments. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
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What it tests

  • Not listed
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Where

4 sites
Humanitas Research Hospital (Rozzano - Milan, Italy)
Milan, Italy
Hospital de la Luz
Lispon, Portugal
Teknon Medical Center
Barcelona, Spain
Virgen del Rocio University Hospital
Seville, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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