Identifying patients with cardiomyopathy for potential heart transplantation
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
This study is trying to find new ways to identify and understand cardiomyopathy in patients to better predict if they might need a heart transplant in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 3 sites (Bologna, Emilia-Romagna/Bologna and 2 other locations) |
| Trial ID | NCT06813443 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new diagnostic and prognostic markers for cardiomyopathy (CMP) to better predict disease progression, particularly towards heart failure or the need for heart transplantation. It will focus on emerging techniques such as microRNAs and spatial transcriptomics to gain insights into the underlying mechanisms of CMP. Patients with various forms of CMP, including hypertrophic and dilated cardiomyopathy, will undergo comprehensive clinical evaluations and molecular studies. The study will collect data from both retrospective and prospective cohorts across multiple centers in Italy.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 years and older diagnosed with cardiomyopathy according to international guidelines.
Not a fit: Patients without a diagnosis of cardiomyopathy or those who do not meet the age criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and management strategies for patients with cardiomyopathy, potentially enhancing their outcomes.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for cardiomyopathy, but this approach utilizing microRNAs and spatial transcriptomics is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with CMP according to current international guidelines * Age ≥ 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) Exclusion Criteria: * none
Where this trial is running
Bologna, Emilia-Romagna/Bologna and 2 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Emilia-Romagna/Bologna, Italy (Recruiting)
- Dipartimento di Scienze Toraciche Cardiovascolari, Fondazione Policlinico Universitario A. Gemelli IRCSS di Roma — Roma, Lazio/Roma, Italy (Not_yet_recruiting)
- Azienda Ospedaliero-Universitaria Careggi di Firenze — Florence, Toscana/Firenze, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Elena Biagini, MD, PhD — IRCCS Azienda Ospedaliero-Universitaria
- Study coordinator: Elena Biagini, MD, PhD
- Email: elena.biagini@aosp.bo.it
- Phone: +39051214483
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.