Predicting Ventricular Tachycardia Events in Patients with Non-Ischemic Cardiomyopathy

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 aims to improve risk stratification for sudden cardiac death in patients with non-ischemic cardiomyopathy by analyzing the relationship between various cardiac imaging parameters and the occurrence of ventricular tachycardia or sudden cardiac death. It will involve a primary analysis of patients with no previous arrhythmia evidence and will validate predictors of these events in a prospective cohort. Additionally, the study will evaluate changes in scar characteristics over time using late gadolinium enhancement cardiac magnetic resonance imaging. The goal is to enhance understanding of arrhythmic risk in this patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Humanitas Research Hospital (Rozzano - Milan, Italy)
  Milan, Italy, Italy Recruiting
• Hospital de la Luz
  Lispon, Portugal, Portugal Recruiting
• Teknon Medical Center
  Barcelona, Barcelona, Spain Recruiting
• Virgen del Rocio University Hospital
  Seville, Sevilla, Spain Recruiting

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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.