National Study of Wild-Type ATTR Amyloidosis Patients Receiving Tafamidis Treatment Monitoring Heart Rhythm and Treatment Needs in Real-World Care

What this Trial Is About

Researchers are studying patients with wild-type transthyretin amyloidosis ATTRwt, a condition affecting the heart, to monitor heart rhythm disturbances and treatment needs while on tafamidis 61 mg. The study focuses on patients with cardiac amyloidosis who are at risk of developing irregular heart rhythms, particularly those with baseline heart conduction blocks. This observational study follows Italian Medicines Agency regulations and aims to better understand rhythm issues and medication requirements in real-world clinical settings. Patients already receiving or starting tafamidis 61 mg will be clinically evaluated before starting treatment and then every six months to determine if they can continue therapy. During these visits, doctors will collect data on heart rhythm disturbances and the dosage of diuretics like furosemide needed. Holter ECG monitoring, which records the hearts electrical activity over time, will be performed as requested by the physician after each clinical evaluation. Participants will attend regular physical examinations every six months, where their heart rhythm and medication needs are assessed. The study will track the occurrence of atrial tachy-arrhythmias and brady-arrhythmias requiring pacemaker or defibrillator implantation over 18 months. Additionally, patient diuretic doses will be recorded. This monitoring helps researchers understand disease progression and treatment effects, with the overall participation lasting at least 18 months.

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