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Taking people in ItalyNo phase

Studies heart muscle diseases and their rhythm and inflammation features in patients

Follows people with non-ischemic heart muscle diseases to study diagnosis, outcomes and treatment.

Key facts

Who runs it
Scientific Institute San Raffaele
Where
Milan, ItalySee the site
Trial code
Registry title
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Status
Recruiting
People taking part
15,000 people, planned
Started
30 Jan 2018
Expected to end
31 Dec 2035
Type of study
Observational, 4 groups
Treatments tested
  • Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
  • Support treatment, cardiac medical treatment, aetiology-specific treatment
Record updated
23 September 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 suspected or proven non-ischemic cardiomyopathy (a heart muscle disease not caused by blocked heart arteries), with or without rhythm problems.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Suspected or proven non-ischemic cardiomyopathy, or a gene type consistent with one. This includes dilated, hypertrophic, restrictive and arrhythmogenic forms, among others.
Biomarker or test result
A gene type consistent with a non-ischemic cardiomyopathy can also count as a way in.

Main reasons for not taking part

  • No written informed consent
  • Proven heart disease other than non-ischemic cardiomyopathy
  • Not enough tests to diagnose cardiomyopathy, find rhythm problems or detect heart muscle inflammation
  • For people enrolled retrospectively: no longer in active follow-up at the enrolling center

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Written informed consent. For pediatric patients, consent will be obtained by parents, according to the laws applicable in each of the participating countries
  • Clinical suspicion of NICM, and/or proven diagnosis of any NICM and/or genotype consistent with any NICM; NICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic/autoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge

Who cannot take part

  • Proven diagnosis of cardiac disease alternative to NICM
  • Lack of diagnostic workup suitable for diagnosing NICM, detecting arrhythmias, or detecting M-Infl
  • Absent informed consent
  • For patients retrospectively enrolled: lack of active status of follow-up at the enrolling center

Where in Italy

  • IRCCS San Raffaele Scientific InstituteMilan, ItalyContact: Giovanni Peretto, MDTaking people

About the trial

What the trial wants to find out

Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the myocardium. The main identified forms include dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy (RCM), and arrhythmogenic cardiomyopathy proper (ACM). More recently, further forms of cardiomyopathy have been described, less common and not uniquely classifiable, including: uncompressed myocardium (LVNC), peripartum cardiomyopathy (PPCM), structural correlates of arrhythmogenic mitral valve prolapse (AMVP), Anderson-Fabry disease (AFD), NICM associated with multi- system neuromuscular or autoimmune diseases, lysosomal diseases, glycogenosis, mitochondrial cytopathies and canal diseases with structural substrates. Finally, there are "overlap" forms, characterized by the sharing in the same subject of characteristic aspects of two or more of the above- mentioned diseases; and of the "undefined" forms, which to date do not reach the diagnostic criteria for any of the above-mentioned diseases.

Read full original descriptionShow less

To the best of current knowledge, there are two points discovered in scientific research, namely the description of the arrhythmogenic and "inflammatory" phenotypes in a broad sense, which are summarized here with the acronym AINICM. In detail:

1. Arrhythmic manifestations account for the arrhythmogenic component of AINICM, which is not limited to ACM proper. In fact, most of the above diseases have a non-arrhythmic clinical presentation and a prevailing tendency to evolve towards a picture of cardiovascular decompensation. Although sudden arrhythmic death has been described throughout the spectrum of AINICM, early arrhythmic manifestations of such diseases have an unknown prevalence, an uncertain association with different disease genotypes and phenotypes, and still uncertain predictivity of long-term arrhythmic risk. At the same time, optimal diagnostic and therapeutic pathways in arrhythmias associated with AINICM are still being studied. 2. Myocardial inflammation (M-Infl) accounts for the inflammatory component of AINICM, and has recently been described in association with many AINICM on a genetic basis, including undefined and arrhythmic forms. The data is of high interest not only in the diagnostic, but also in prognostic and therapeutic field. In fact, on the one hand the presence of M-Infl seems to have a physio- pathological role in AINICM; on the other, as already known in myocarditis, the optimal therapeutic paths of arrhythmias may differ in patients with and without M-Infl; in particular, also in the light of the preliminary data available in adult and paediatric AINICM, the inflammatory forms are expected to respond better to immunosuppressive therapy, the arrhythmogenic ones to an ablative therapy with frequent need of implantation of cardiac devices.

Based on the clinical presentation, NICM patients will be divided into arrhythmic (AINICM) and non-arrhythmic patients as study and control groups , respectively. The AINICM group will include presentation with ventricular fibrillation (VF), either sustained or non-sustained ventricular tachycardia (VT; NSVT), frequent premature ventricular complexes (PVC), supraventricular arrhythmias (SVA) and bradyarrhythmias (BA). Clinical presentations other than arrhythmic, including chest pain and heart failure, will define the control group. In parallel, as shown in Figure 1, patients with any evidence of M-Infl will be compared with those showing no signs of M-Infl.

The 4 groups in the trial

  • Arrhythmic and Inflammatory (AINICM)

    The AINICM group will include presentation with ventricular fibrillation (VF), either sustained or non-sustained ventricular tachycardia (VT; NSVT), frequent premature ventricular complexes (PVC), supraventricular arrhythmias (SVA) and bradyarrhythmias (BA). The arrhythmogenic and the inflammatory non-ischemic cardiomyopathies (AINICM) will be characterized by means of a multimodal diagnostic workup, which is a combination ofgenetic tests, different techniques of cardiac imaging, laboratory tests and biomarkers, histology, and electrophysiological tools, collecting all the clinical variables in a registry.

    Treatment: Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Non-arrhythmic and inflammatory (INICM)

    The inflammatory component will be diagnosed by means of a multidisciplinary workup (i.e. EMB, PET).

    Treatment: Support treatment, cardiac medical treatment, aetiology-specific treatment

  • Arrhythmic and Non-inflammatory (ANICM)

    The arrhythmic component will be diagnosed by means of a multidisciplinary work-up (i.e. SAECG, Arrhythmia monitoring, Stress test, CT scan, EAM, Electrophysiological test)

    Treatment: Support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Non-arrhythmic and Non-inflammatory (NICM)

    NICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic/autoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge.

    Treatment: Support treatment, cardiac medical treatment, aetiology-specific treatment

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
Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.
Plain-language title
Studies heart muscle diseases and their rhythm and inflammation features in patientsGenerated 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
23 September 2024