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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Paolo Milani
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor institution