Cardiac AmyloidosisEcho-AMYNCT05760287
Echocardiographic Characterization of Cardiac Amyloidosis
An observational study of Cardiac Amyloidosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Amyloidosis
- How many people
- 255 participants
- Where
- 1 siteItaly
- Study dates
- 9 Dec 2022to 2 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the retrospective phase, patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Agostino Gemelli between January 2020 and November 2022 will be enrolled. In the prospective phase, patients with the same features evaluated between December 2022 and December 2028.
Who may be able to join
- 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.
Who cannot join
- missing data
- decline to the study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, RM, 00168
francesca graziani, MD, +31 3313957433, francesca.graziani@policlinicogemelli.it
maria chiara meucci, MD, + 31 3313957433, mariachiara.meucci@guest.policlinicogemelli.it
About this study
Official title: Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
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.
- Conditions
- Cardiac Amyloidosis
- Keywords
- echocardiography, left ventricle
- Medical subject headings
- Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in echocardiographic parameters (in patients receiving or not specific treatment)
variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy
Measured: 6 months
cardiovascular outcomes
composite endpoint of death and heart failure hospitalization
Measured: 24 months
Secondary outcomes (1)
major cardiac arrhythmias
bradyarrhythmia, new-onset atrial fibrillation, ventricular tachycardia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start9 Dec 2022
- Primary completion2 Dec 2030 (estimated)
- Study completion2 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AmyloidosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesca Graziani, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760287
- Sponsor's protocol ID
- 5308
- Acronym
- Echo-AMY
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Characterization of Cardiac Amyloidosis: an Observational Study
- ClinicalTrials.gov ID
- NCT05760287
- Acronym / sponsor ID
- Echo-AMY / 5308
- Conditions
- Cardiac Amyloidosis
- Keywords
- echocardiography, left ventricle
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 2 Dec 2030 (estimated)
- Study completion
- 2 Feb 2031 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the retrospective phase, patients with cardiac amyloidosis evaluated at the Fondazione Policlinico Agostino Gemelli between January 2020 and November 2022 will be enrolled. In the prospective phase, patients with the same features evaluated between December 2022 and December 2028.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- missing data
- decline to the study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in echocardiographic parameters (in patients receiving or not specific treatment)
Time frame: 6 months
variation in global longitudinal strain, diastolic parameters and degree of ventricular hypertrophy
cardiovascular outcomes
Time frame: 24 months
composite endpoint of death and heart failure hospitalization
1 secondary outcome
major cardiac arrhythmias
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
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Essen Amyloidosis Registry
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A Phase 3 Study of NTLA-2001 in ATTRv-PN
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MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Graziani principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Amyloidosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Graziani, MD (00390630154432, francesca.graziani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in echocardiographic parameters (in patients receiving or not specific treatment) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.