Clinical, Instrumental, and Molecular Circulating and Tissue microRNAs Characterization of Patients With Cardiomyopathy to Identify Critical Patients With Severe Organ Failure to be Candidates for Cardiac Transplantation

What this Trial Is About

Researchers are investigating new diagnostic and prognostic markers for cardiomyopathy CMP to better predict how the disease progresses, especially toward heart failure or the need for heart transplantation. The study focuses on microRNAs and spatial transcriptomics, promising techniques that may reveal important disease mechanisms. Patients with various types of CMP, including hypertrophic, dilated, arrhythmogenic, and forms related to amyloidosis and Fabry disease, are being evaluated to improve diagnosis and management. This observational study has both retrospective and prospective parts. Retrospective data from patients treated since 1990 will be collected from medical records, while prospective patients are enrolled from outpatient or inpatient settings at several medical centers. Patients undergo standard clinical tests such as ECG, echocardiograms, cardiac magnetic resonance CMR, biopsies, and genetic testing. Additional molecular analyses on blood plasma and cardiac tissue will be done for some prospective patients. Tissue samples collected during routine biopsies or surgeries will be processed for advanced RNA analyses. Participants will provide informed consent and be evaluated according to clinical needs without a set minimum follow-up time. Data collected include demographics, medical and family history, symptoms, treatments, and genetic information. Researchers will use this information to identify new biomarkers related to CMP diagnosis and prognosis. The main outcome focuses on risk stratification over a follow-up of two years after a 30-month enrollment period, with data analysis lasting six months. Molecular studies of gene expression and microRNAs will also be analyzed during this time.

Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation