AmyloidosisNOTE-ATTRNCT06251778
NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis
An observational study of Amyloidosis and Amyloidosis Cardiac, run by Paolo Milani at 1 site in Italy.
Trial summary
All ATTRwt patients on tafamidis 61 mg treatment will be clinically evaluated before treatment initiation and subsequently every six months for the eligibility to continue tafamidis treatment, according to Italian Medicines Agency regulations. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Amyloidosis, Amyloidosis Cardiac, ATTR Amyloidosis Wild Type
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jan 2024to 26 Jan 2027
- 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: All patients with a diagnosis of ATTRwt disease and eligible for tafamidis treatment according to the national drug regulatory agency criteria and no prior history of atrial trachy-arrhythmia and/or bradyarrhythmias in their past medical history will undergo screening procedure to be enrolled in the present study.
Who may be able to join
- Diagnosis of ATTRwt amyloidosis.
- 18 years or older;
- evidence of cardiac involvement at echocardiography or cardiac MRI.
- No known prior history of atrial fibrillation or major bradyarrhythmia (second degree atrioventricular block, third-degree atrioventricular block, high-grade atrioventricular block or alternating right and left branch block)
- female patients who are postmenopausal for at least 1 year before the screening visit
- patients on therapy or candidates for therapy with tafamidis 61 mg
- voluntary written consent must be given before performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Who cannot join
- Non-ATTR amyloidosis;
- NYHA class III and IV;
- Pregnant or nursing women;
- Previous pacemaker implantation;
- any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a fully comprehension of the written consent form
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 IRCCS Policlinico San Matteo
Pavia, 27100
Paolo Milani, MD, +390382502994, segreteria.amiloidosi@smatteo.pv.it
About this study
Official title: NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis: Real World Prospective Study
All ATTRwt patients on tafamidis 61 mg treatment will be clinically evaluated before treatment initiation and subsequently every six months for the eligibility to continue tafamidis treatment, according to Italian Medicines Agency regulations. C onsidering the significant risk of developing heart rhythm disturbances due to cardiac amyloidosis, especially in transthyretin form (ATTRwt), in routine clinical practice a stricter heart rhythm monitoring is recommended in ATTRwt patients. Moreover, particular attention is usually paid for those who present atrio-ventricular and/or intraventricular block at the baseline electrocardiogram. Data about rhythm disturbances and diuretic dose need will be collected during the planned physical examination every six months and the Holter ECG monitoring requested by the physician at the end of every planned clinical evaluation.
- Conditions
- Amyloidosis, Amyloidosis Cardiac, ATTR Amyloidosis Wild Type
- Medical subject headings
- Amyloidosis, Amyloid Neuropathies, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of atrial tachy-arrhythmia and brady-arrhythmias requiring pacemaker and/or defibrillator
All ATTRwt patients eligible for tafamidis with no prior history of atrial tachy-arrhythmia or brady-arrhythmias will be prospectively enrolled. The events (arrythmias incidence) will be collected by the usually rhythm monitoring that physician will recommend at the end of clinical evaluation according to clinical practice
Measured: 18 months
Secondary outcomes (1)
patient diuretic dose need (i.e. Furosemide), reported as mg/Kg/die
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start26 Jan 2024
- Primary completion26 Jan 2027 (estimated)
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paolo Milani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolo Milani, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251778
- Sponsor's protocol ID
- AC-022-IT
- Acronym
- NOTE-ATTR
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2024
- Last updated
- 16 Apr 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 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis: Real World Prospective Study
- ClinicalTrials.gov ID
- NCT06251778
- Acronym / sponsor ID
- NOTE-ATTR / AC-022-IT
- Conditions
- Amyloidosis, Amyloidosis Cardiac, ATTR Amyloidosis Wild Type
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Paolo MilaniUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 9 Feb 2024 (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.
All ATTRwt patients on tafamidis 61 mg treatment will be clinically evaluated before treatment initiation and subsequently every six months for the eligibility to continue tafamidis treatment, according to Italian Medicines Agency regulations. C onsidering the significant risk of developing heart rhythm disturbances due to cardiac amyloidosis, especially in transthyretin form (ATTRwt), in routine clinical practice a stricter heart rhythm monitoring is recommended in ATTRwt patients. Moreover, particular attention is usually paid for those who present atrio-ventricular and/or intraventricular block at the baseline electrocardiogram. Data about rhythm disturbances and diuretic dose need will be collected during the planned physical examination every six months and the Holter ECG monitoring requested by the physician at the end of every planned clinical evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of ATTRwt disease and eligible for tafamidis treatment according to the national drug regulatory agency criteria and no prior history of atrial trachy-arrhythmia and/or bradyarrhythmias in their past medical history will undergo screening procedure to be enrolled in the present study.
Key inclusion criteria (7 listed)
- Diagnosis of ATTRwt amyloidosis.
- 18 years or older;
- evidence of cardiac involvement at echocardiography or cardiac MRI.
- No known prior history of atrial fibrillation or major bradyarrhythmia (second degree atrioventricular block, third-degree atrioventricular block, high-grade atrioventricular block or alternating right and left branch block)
- female patients who are postmenopausal for at least 1 year before the screening visit
Key exclusion criteria (5 listed)
- Non-ATTR amyloidosis;
- NYHA class III and IV;
- Pregnant or nursing women;
- Previous pacemaker implantation;
- any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with a fully comprehension of the written consent form
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
Cumulative incidence of atrial tachy-arrhythmia and brady-arrhythmias requiring pacemaker and/or defibrillator
Time frame: 18 months
All ATTRwt patients eligible for tafamidis with no prior history of atrial tachy-arrhythmia or brady-arrhythmias will be prospectively enrolled. The events (arrythmias incidence) will be collected by the usually rhythm monitoring that physician will recommend at the end of clinical evaluation according to clinical practice
1 secondary outcome
patient diuretic dose need (i.e. Furosemide), reported as mg/Kg/die
Time frame: 18 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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Amyloidosis and Amyloidosis Cardiac, run by Paolo Milani 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 7 inclusion and 5 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 16 Apr 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of atrial tachy-arrhythmia and brady-arrhythmias requiring pacemaker and/or defibrillator (time frame: 18 months). 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 16 Apr 2026.