Actively Recruiting
National Referral Center Study of Transthyretin Amyloid Cardiomyopathy (ATTR) Patients on Tafamidis: Real World Prospective Study
Led by Paolo Milani · Updated on 2026-04-16
200
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
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 heart's 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.
CONDITIONS
Brief 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 shown by echocardiography or cardiac MRI
- No known 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
- Currently on or eligible for therapy with tafamidis 61 mg
- Voluntary written consent provided before any study-related procedures 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 months
Participants who are on tafamidis are observed for cardiac arrhythmias and medication needs over time.
Regular visits during the 18-month period
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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