CardiomyopathyAMI-ERNCT06866912
Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis
An observational study of Cardiomyopathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
observational epidemiological study of patients affected by systemic amyloidosis Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cardiomyopathy
- How many people
- 750 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 31 Aug 2033
- How long will I take part?
- 10 Years
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes all adult patients referred to the participating centers with a diagnosis of amyloidosis or carriers of pathogenic mutations starting from 01/01/1981 diagnosed in accordance with current international guidelines.
Who may be able to join
- patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene
- minimum age of 18 years at the time of diagnosis
- obtaining informed consent
Who cannot join
- nothing
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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Simone longhi, MD, 00390512149039, simone.longhi@aosp.bo.it
About this study
observational epidemiological study of patients affected by systemic amyloidosis
- Conditions
- Cardiomyopathy
- Keywords
- Cardiac amyloidosis
- Medical subject headings
- Cardiomyopathies, Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of amyloidosis
prevalence of amyloidosis in patients admitted to the UOs participating in the study
Measured: throughout the study period until 10 years
incidence of amyloidosis
incidence of amyloidosis in patients admitted to the UOs participating in the study
Measured: throughout the study period until 10 years
Observational epidemiological study of patients with systemic amyloidosis
characteristics of each etiology in terms of baseline clinical data
Measured: throughout the study period until 10 years
Types of cardiac clinical phenotype
Cardiac clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Measured: throughout the study period until 10 years
Incidence of mixed clinical phenotype
Mixed clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Measured: throughout the study period until 10 years
Incidence of hospitalization for heart failure
Incidence during follow-up of hospitalization for heart failure
Measured: throughout the study period until 10 years
Incidence of hospitalization for onset of arrhythmias
Incidence during follow-up of hospitalization for onset of arrhythmias
Measured: throughout the study period until 10 years
Incidence of hospitalization for stroke
Incidence of hospitalization for stroke during follow-up
Measured: throughout the study period until 10 years
incidence of pacemaker implantation
incidence during follow-up of need for pacemaker implantation
Measured: throughout the study period until 10 years
incidence of pacemaker implantation of defibrillator
incidence during follow-up of need for defibrillator implantation
Measured: throughout the study period until 10 years
Incidence of cardiac transplantation
incidence during follow-up of need for cardiac transplantation
Measured: throughout the study period until 10 years
Incidence of transplantation of other solid organs
incidence during follow-up of need for other solid organ transplantation
Measured: throughout the study period until 10 years
Mortality
total mortality during follow up
Measured: throughout the study period until 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Sep 2023
- Primary completion31 Aug 2033 (estimated)
- Study completion31 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 750 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Longhi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866912
- Sponsor's protocol ID
- AMI-ER
- Acronym
- AMI-ER
- Status last verified
- Oct 2024
- First submitted
- 29 Jan 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidenciality
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Epidemiological Study of Patients Suffering From Systemic Amyloidosis
- ClinicalTrials.gov ID
- NCT06866912
- Acronym / sponsor ID
- AMI-ER / AMI-ER
- Conditions
- Cardiomyopathy
- Keywords
- Cardiac amyloidosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Aug 2033 (estimated)
- Study completion
- 31 Aug 2033 (estimated)
- First posted
- 10 Mar 2025 (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.
observational epidemiological study of patients affected by systemic amyloidosis
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all adult patients referred to the participating centers with a diagnosis of amyloidosis or carriers of pathogenic mutations starting from 01/01/1981 diagnosed in accordance with current international guidelines.
Key inclusion criteria (3 listed)
- patients diagnosed with amyloidosis or asymptomatic carriers of mutations in the transthyretin gene
- minimum age of 18 years at the time of diagnosis
- obtaining informed consent
Key exclusion criteria (1 listed)
- nothing
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
prevalence of amyloidosis
Time frame: throughout the study period until 10 years
prevalence of amyloidosis in patients admitted to the UOs participating in the study
incidence of amyloidosis
Time frame: throughout the study period until 10 years
incidence of amyloidosis in patients admitted to the UOs participating in the study
Observational epidemiological study of patients with systemic amyloidosis
Time frame: throughout the study period until 10 years
characteristics of each etiology in terms of baseline clinical data
Types of cardiac clinical phenotype
Time frame: throughout the study period until 10 years
Cardiac clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of mixed clinical phenotype
Time frame: throughout the study period until 10 years
Mixed clinical phenotype in patients who at baseline are asymptomatic carriers of pathogenic mutations
Incidence of hospitalization for heart failure
Time frame: throughout the study period until 10 years
Incidence during follow-up of hospitalization for heart failure
Incidence of hospitalization for onset of arrhythmias
Time frame: throughout the study period until 10 years
Incidence during follow-up of hospitalization for onset of arrhythmias
Incidence of hospitalization for stroke
Time frame: throughout the study period until 10 years
Incidence of hospitalization for stroke during follow-up
incidence of pacemaker implantation
Time frame: throughout the study period until 10 years
incidence during follow-up of need for pacemaker implantation
incidence of pacemaker implantation of defibrillator
Time frame: throughout the study period until 10 years
incidence during follow-up of need for defibrillator implantation
Incidence of cardiac transplantation
Time frame: throughout the study period until 10 years
incidence during follow-up of need for cardiac transplantation
Incidence of transplantation of other solid organs
Time frame: throughout the study period until 10 years
incidence during follow-up of need for other solid organ transplantation
Mortality
Time frame: throughout the study period until 10 years
total mortality during follow up
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 10 Mar 2025.
- Individual participant dataSharing planned: No. Confidenciality
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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.
Simone Longhi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Cardiomyopathy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 3 inclusion and 1 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 10 Mar 2025. 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 simone longhi, MD (00390512149039, simone.longhi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of amyloidosis (time frame: throughout the study period until 10 years). The study lists 13 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 10 Mar 2025.