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

Paolo Milani

Status: Enrolling

Conditions: ATTR Amyloidosis Wild Type; Amyloidosis Cardiac; Amyloidosis

Study type: Observational

Funder types: Other

Identifiers

NCT06251778

AC-022-IT

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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performance of any study-related procedure not part of standard medical care with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.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