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

Last updated: July 10, 2024
Sponsor: Paolo Milani
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyloidosis

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT06251778
AC-022-IT
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 (seconddegree atrioventricular block, third-degree atrioventricular block, high-gradeatrioventricular block or alternating right and left branch block)

  • female patients who are postmenopausal for at least 1 year before the screeningvisit

  • patients on therapy or candidates for therapy with tafamidis 61 mg

  • voluntary written consent must be given before performance of any study-relatedprocedure not part of standard medical care with the understanding that consent maybe withdrawn by the patient at any time without prejudice to future medical care.

Exclusion

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'sopinion, potentially interfere with a fully comprehension of the written consentform

Study Design

Total Participants: 200
Study Start date:
January 26, 2024
Estimated Completion Date:
January 26, 2026

Connect with a study center

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

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