NCT06813443 Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation
| NCT ID | NCT06813443 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Cardiomyopathies |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2023-02-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to identify new diagnostic and prognostic markers for CMP that can help predict disease progression. In particular, the study will focus on microRNAs (miRNAs) and spatial transcriptomics, which are emerging techniques that may provide insights into the underlying disease mechanisms. By understanding these markers, the investigators hope to improve the way the investigators diagnose and manage CMP, particularly in terms of predicting progression to heart failure or heart transplantation. The study will evaluate patients with hypertrophic cardiomyopathy (e.g., sarcomeric forms, Anderson-Fabry disease, AL, and TTR cardiac amyloidosis), dilated cardiomyopathy and arrhythmogenic cardiomyopathy. These patients will undergo clinical evaluations, including ECG, echocardiograms, CMR, biopsy analysis, and genetic testing, as well as molecular studies such as transcriptomics and miRNA analysis. This comprehensive approach aims to identify potential new biomarkers for diagnosing and predicting the disease course.
Eligibility 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
Contact & Investigator
Elena Biagini, MD, PhD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria
Frequently Asked Questions
Who can join the NCT06813443 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cardiomyopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813443 currently recruiting?
Yes, NCT06813443 is actively recruiting participants. Contact the research team at elena.biagini@aosp.bo.it for enrollment information.
Where is the NCT06813443 trial being conducted?
This trial is being conducted at Bologna, Italy, Roma, Italy, Florence, Italy.
Who is sponsoring the NCT06813443 clinical trial?
NCT06813443 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Elena Biagini, MD, PhD at IRCCS Azienda Ospedaliero-Universitaria. The trial plans to enroll 700 participants.