Echocardiographic evaluation of cardiac amyloidosis
Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
This study is testing new heart imaging techniques to see if they can help tell cardiac amyloidosis apart from other heart problems and check how well tafamidis treatment can improve heart damage in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 255 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT05760287 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with cardiac amyloidosis at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS in Rome, Italy. It aims to utilize advanced echocardiographic techniques, including two- and three-dimensional speckle-tracking analysis, to differentiate cardiac amyloidosis from other similar heart conditions. Additionally, the study will assess the reversibility of myocardial damage in response to tafamidis treatment and explore new echocardiographic predictors of adverse cardiovascular outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with cardiac amyloidosis who meet the inclusion criteria set by the European Society of Cardiology.
Not a fit: Patients who do not have cardiac amyloidosis or those who decline participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy and treatment monitoring for patients with cardiac amyloidosis.
How similar studies have performed: While this approach is observational, similar studies utilizing advanced echocardiographic techniques have shown promise in improving diagnostic capabilities for cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with cardiac amyloidosis, defined according to the recommendations provided by the working group of the european society of cardiology, with clinical, electrocardiographic ed echocardiographic data and with at least one follow-up visit. Exclusion Criteria: * missing data * decline to the study participation
Where this trial is running
Roma, RM
- Fondazione Policlinico Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Francesca Graziani, MD
- Email: francesca.graziani@policlinicogemelli.it
- Phone: 00390630154432
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.