Actively Recruiting
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
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-07
700
Participants Needed
3
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with CMP according to current international guidelines
- Age 63 12 years at the time of diagnosis
- Obtaining informed consent from the patient and the parent or legal guardian (in the case of patients aged < 18 years)
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months during the prospective enrollment phase and continuing up to 2 years follow-up
Participants who undergo routine care for cardiomyopathy are observed, and data from clinical records, genetic investigations, and instrumental tests are collected as part of standard clinical practice.
Visits as part of routine clinical care, including outpatient visits and hospitalizations
Duration - During the prospective enrollment and follow-up period
In a subgroup of participants, additional blood and cardiac tissue samples are collected during routine clinical procedures for molecular analysis without affecting standard care.
Sample collection occurs alongside standard clinical visits and procedures
Trial Site Locations
Total: 3 locations
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Emilia-Romagna/Bologna, Italy, 40138
Actively Recruiting
2
Dipartimento di Scienze Toraciche Cardiovascolari, Fondazione Policlinico Universitario A. Gemelli IRCSS di Roma
Roma, Lazio/Roma, Italy, 00161
Not Yet Recruiting
3
Azienda Ospedaliero-Universitaria Careggi di Firenze
Florence, Toscana/Firenze, Italy, 50134
Not Yet Recruiting
Research Team
E
Elena Biagini, MD, PhD
S
Silvia Palmieri, M. Sc.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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