ClinicalTrials.gov record NCT06251778

NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 23, 2026

NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis: Real World Prospective Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationItaly
AI summaryWhat this study is about, 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 prospective observational study follows people with wild-type ATTR cardiac amyloidosis who are starting or receiving tafamidis. Participants have clinical evaluations before treatment initiation and every six months; rhythm monitoring (including Holter ECG) is performed when the treating physician requests it. The study records arrhythmia events and diuretic dose changes, with outcomes collected over 18 months.

What it is studying. The study is measuring how often atrial tachy-arrhythmias and brady-arrhythmias that may require a pacemaker or defibrillator occur in ATTRwt patients on tafamidis, and it is tracking patients' diuretic dose needs. Events and doses are recorded from routine clinical evaluations and physician-ordered rhythm monitoring.

What the researchers hope to learn. To measure the cumulative incidence of atrial tachy-arrhythmia and brady-arrhythmias requiring pacemaker and/or defibrillator in ATTRwt patients on tafamidis, and to describe changes in patients' diuretic dose needs over 18 months.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

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.

You would have a clinical evaluation before starting tafamidis and then repeat clinical visits every six months. At each visit the physician will record heart‑rhythm symptoms and diuretic dose, and may order Holter ECG monitoring at the end of the clinical evaluation; rhythm-monitoring results and any arrhythmia events (including those leading to pacemaker or defibrillator) will be collected. These events and diuretic dose will be followed and recorded for an 18‑month period. The registry record does not list other tests, samples, or participant support services.

How the study is structured. This is a prospective, observational cohort study. People with ATTRwt who are on or starting tafamidis are enrolled and followed over time. Clinical evaluations occur before treatment start and every six months; physicians request Holter ECG rhythm monitoring after evaluations according to usual care. Researchers collect reports of arrhythmias and record diuretic dose, with primary outcomes tracked for 18 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Amyloidosis; Amyloidosis Cardiac; ATTR Amyloidosis Wild Type. Does it apply to my diagnosis?
  • 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 ATTRv amyloidosis

This trial is also listed on this site under wild-type ATTR amyloidosis.

Clinical trials106 trials listed for ATTRv amyloidosisEvery trial the registry lists for ATTRv amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in ATTRv amyloidosis researchLatest monthly update: September 2026. Includes: Gene-silencing drugs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 26, 2024
Primary completion
Jan 26, 2027 (estimated)
Study completion
Jan 26, 2027 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
Apr 16, 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
Paolo Milani

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

intraventricular
Given directly into the fluid-filled spaces (ventricles) inside the brain, usually through an implanted catheter or reservoir.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
electrocardiogram
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
screening visit
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
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.

← Back to clinical trials