About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Non-ATTR amyloidosis;
NYHA class III and IV;
Pregnant or nursing women;
Previous pacemaker implantation;
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
patient diuretic dose need (i.e. Furosemide), reported as mg/Kg/die
Sponsors and contacts
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Paolo Milani
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor institution