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Predicting dangerous heart rhythms in non-ischemic cardiomyopathy using heart MRI images

Tests whether heart MRI images can predict dangerous rhythm events in adults with non-ischemic cardiomyopathy.

Key facts

Who runs it
Centro Medico Teknon
Where
Milan, ItalySee the siteAlso in 2 other countries, 3 sites
Trial code
Registry title
Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy
Status
Recruiting
People taking part
500 people, planned
Started
7 Oct 2024
Expected to end
23 Feb 2027
Type of study
Observational
Record updated
12 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a heart muscle disease that is not caused by blocked heart arteries, who have already had a heart MRI with contrast and have had no dangerous heart rhythm events.

Age
18 years or older
Sex
All sexes can join
Disease stage
Non-ischemic heart disease involving the left ventricle, whatever the ejection fraction (LVEF): dilated cardiomyopathy, non-dilated left ventricular cardiomyopathy, or post-myocarditis cardiomyopathy. Life expectancy of more than 1 year with a good functional status.
Earlier treatment
No concomitant investigational treatments.
Biomarker or test result
At least one late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) scan already done, with the data available. No ventricular arrhythmia events at the time of the first LGE-CMR.

Main reasons for not taking part

  • Pregnancy
  • Life expectancy of less than 1 year, or bad functional status (NYHA IV)
  • Other structural heart diseases (for example ischemic, congenital, or arrhythmogenic right ventricular cardiomyopathy)
  • Sustained ventricular arrhythmias documented before the first LGE-CMR
  • No LGE-CMR at enrolment, or LGE-CMR data not available

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • Diagnosis of non-ischemic heart disease involving the left ventricle, irrespectively of LVEF. This diagnosis includes:; Dilated cardiomyopathy (DCM); Non-dilated left ventricular cardiomyopathy (NDLVC); 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

Who cannot take part

  • Other concomitant structural heart diseases (e.g. ischemic, congenital, arrhythmogenic right ventricular cardiomyopathy etc.)
  • Previously documented sustained ventricular arrhythmias at the time of 1st LGE-CMR
  • Concomitant investigation treatments
  • Pregnancy
  • Life expectancy of < 1 year, or bad functional status (NYHA IV functional class)
  • No LGE-CMR at time of enrollment or LGE-CMR data not available
  • 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 in Italy

Also in 2 other countries, 3 sites

  • Humanitas Research Hospital (Rozzano - Milan, Italy)Milan, ItalyContact: Diego Penela, MD, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

As for most structural heart diseases (SHD), scar-related reentry has been addressed as the pathophysiological mechanism of ventricular arrhythmias (VAs) in patients with NICM, with fibrotic tissue being the substrate of this reentry. Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) is the gold standard for the non-invasive visualization and characterization of the myocardial fibrosis and according to retrospective studies is detected in nearly 30% of patients with NICM.

In latest years, several studies and subsequent metanalyses have explored the correlation between CMR-detected LGE and occurrence of VAs, showing that presence, extent, location (septal vs lateral) and patten (focal vs multifocal vs ring-like) of non-ischemic fibrosis help in stratifying arrhythmic risk.

Nonetheless, scar heterogeneity (that is, inherent composition of dense scars vs border zone (BZ), presence of strands of viable myocardium within the scar) has been indicated as a potential novel predictor of VAs. In a recent prospective multicenter registry on patients with class I indication for cardiac resynchronization therapy (CRT) (>60% with NICM), not only scar mass, but even border zone (BZ) mass and presence of BZ channels were identified as independent predictors for VT occurrence in NICM patients.

This BZ mass and BZ channels can be automatically identified using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZ mass might be used as an automatically reproducible criterium to reclassify those patients with NICM at highest risk for developing VAs/SCD in a relatively short period of at least 2 years.

In the present cohort study, the investigators sought to: i) evaluate the usefulness of CMR-derived BZ mass measurement and identification of heterogeneous tissue channels (HTC) (among other scar characteristics derived from image post-processing) to predict the occurrence of VT events in an international, retrospective, multicenter, unselected series of patients with NICM without previous arrhythmia evidence (main study); ii) subsequently validate these predictors of VT occurrence in a prospectively-collected multicenter cohort study (substudy 1); iii) retrospectively evaluate in the subset of patients with > 1 LGE-CMR performed as part of standard clinical practice if any change in BZ mass and HTC presence occurs over time and if this correlates with occurrence of VAs (substudy 2).

The group in the trial

  • Patients with non ischemic cardiomyopathies

    Patients will only be recruited if they fulfill ALL the inclusion criteria: 1. Age \> 18 years. 2. 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 3. Life expectancy of \> 1 year with a good functional status. 4. Signed informed consent. 5. CMR already performed or scheduled for clinical purpose (standard clinical practice). 6. No VA events at the time of the 1st LGE-CMR study.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Image-Based Prediction of Ventricular Tachycardia Events in Non-ischemic Cardiomyopathy, an International Multicenter Study - [The IMPROVE-NICM Study]
Plain-language title
Predicting dangerous heart rhythms in non-ischemic cardiomyopathy using heart MRI imagesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 December 2024