ClinicalTrials.gov record NCT05760287
Echocardiographic Characterization of Cardiac Amyloidosis
Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This single-center observational study collects echocardiograms and clinical data from adults with cardiac amyloidosis seen at Fondazione Policlinico Universitario Agostino Gemelli. It has a retrospective phase (Jan 2020–Nov 2022) and a prospective phase (Dec 2022–Dec 2028). The study focuses on advanced echocardiographic techniques and on links between echo measures, clinical outcomes, and treatment with tafamidis.
What it is studying. The study looks for echocardiographic patterns — including two- and three-dimensional speckle-tracking measures — that may help distinguish cardiac amyloidosis from other causes of thickened heart muscle. It also examines changes in echo measures over time, their relationship with clinical course, and whether echo findings are associated with outcomes such as death, heart-failure hospitalization, or major arrhythmias; it will compare these measures in patients who do and do not receive tafamidis.
What the researchers hope to learn. To describe detailed echocardiographic features of cardiac amyloidosis (including speckle-tracking findings); to evaluate echocardiographic changes after treatment with tafamidis and their correlation with clinical response; and to identify echocardiographic predictors of adverse cardiovascular outcomes (death, heart-failure hospitalization) and major arrhythmias.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is a mono-center observational ambispective study in which patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Rome, Italy) will be enrolled. The primary aim is to investigate echocardiographic findings, particularly using advanced echocardiographic techniques, such as two- and three-dimensional speckle-tracking analysis, that may be helpful in the differential diagnosis between cardiac amyloidosis and other cardiomyopathies with hypertrophic phenotype. Secondary aims are: 1) to evaluate the reversibility of myocardial damage, assessed by echocardiography, in response to a newly available specific treatment for patients with transthyretin-related cardiac amyloidosis (tafamidis) and its correlation with the clinical response 2) to investigate potential novel echocardiographic predictors of adverse cardiovascular outcomes.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an observational study using existing records for the retrospective group and ongoing data collection for the prospective group. Activities include review of clinical records, ECGs and echocardiograms; prospective participants may undergo one or more echocardiograms including advanced two- and three-dimensional speckle-tracking analyses and scheduled follow-up visits. Study staff will track outcomes such as changes in imaging measurements and occurrences of death or heart-failure hospitalization (follow-up reported up to 24 months). The registry does not list invasive procedures.
How the study is structured. A mono-center observational cohort using an ambispective (retrospective plus prospective) cross-sectional approach. No treatments are assigned; investigators will analyze past and new echocardiograms and clinical follow-up data.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
This trial is also listed on this site under ATTRv amyloidosis.
Important dates
- Study start
- Dec 9, 2022
- Primary completion
- Dec 2, 2030 (estimated)
- Study completion
- Feb 2, 2031 (estimated)
- Target enrollment
- 255 participants (estimated)
- Last updated on registry
- Sep 4, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Francesca Graziani, MD 📞 00390630154432 ✉ francesca.graziani@policlinicogemelli.it
- maria chiara meucci, MD 📞 00390630154432 ✉ mariachiara.meucci@guest.policlinicogemelli.it
Participating sites (1)
- Fondazione Policlinico Gemelli IRCCSRecruiting
Roma, RM, 00168 · Italy
- francesca graziani, MD · +31 3313957433 · francesca.graziani@policlinicogemelli.it
- maria chiara meucci, MD · + 31 3313957433 · mariachiara.meucci@guest.policlinicogemelli.it
Terms used on this page · explanations by MedicalUpdates.ai
- echocardiography
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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