Predicting Ventricular Tachycardia Events in Patients with Non-Ischemic Cardiomyopathy
Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy, an International Multicenter Study - [The IMPROVE-NICM Study]
This study is trying to see if certain heart imaging tests can help predict the risk of dangerous heart rhythms and sudden cardiac death in people with non-ischemic cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 4 sites (Milan, Italy and 3 other locations) |
| Trial ID | NCT06730464 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with non-ischemic heart disease such as dilated cardiomyopathy or post-myocarditis cardiomyopathy, who have a good functional status and have undergone at least one cardiac MRI.
Not a fit: Patients with a life expectancy of less than one year, severe functional impairment, or previously documented ventricular arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and prevention strategies for sudden cardiac death in patients with non-ischemic cardiomyopathy.
How similar studies have performed: While this approach is innovative, previous studies have shown mixed results regarding the effectiveness of current risk stratification methods in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Italy and 3 other locations
- 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)
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.