Actively Recruiting
NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis
Led by Paolo Milani · Updated on 2026-04-16
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ATTRwt amyloidosis
- Age 18 years or older
- Evidence of cardiac involvement at echocardiography or cardiac MRI
- No prior history of atrial fibrillation or major bradyarrhythmia (including second or third degree atrioventricular block, high-grade atrioventricular block, or alternating right and left branch block)
- Female patients must be postmenopausal for at least 1 year before screening
- Patients currently on or candidates for tafamidis 61 mg therapy
- Voluntary written consent given before any study procedure not part of standard care
You will not qualify if you...
- Diagnosis of non-ATTR amyloidosis
- New York Heart Association (NYHA) class III or IV heart failure
- Pregnant or nursing women
- Previous pacemaker implantation
- Any serious medical or psychiatric illness that may interfere with understanding the consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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