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

Amyloidosis Clinical Trial

— NOTE-ATTR  

Official title:

NatiOnal Referral cenTEr Study of Transthyretin Amyloid Cardiomyopathy(ATTR) Patients on Tafamidis: Real World Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251778
• Other study ID #: AC-022-IT
• Status: Recruiting
• Start date: January 26, 2024
• Est. completion date: January 26, 2026

Study information

• Verified date: March 2024
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 26, 2026
• Est. primary completion date: January 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Cardiac
• Cardiomyopathies

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Paolo Milani

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of atrial tachy-arrhythmia and brady-arrhythmias requiring pacemaker and/or defibrillator	All ATTRwt patients eligible for tafamidis with no prior history of atrial tachy-arrhythmia or brady-arrhythmias will be prospectively enrolled. The events (arrythmias incidence) will be collected by the usually rhythm monitoring that physician will recommend at the end of clinical evaluation according to clinical practice	18 months
Secondary	patient diuretic dose need (i.e. Furosemide), reported as mg/Kg/die		18 months