Patient outcomes and clinical characteristics of ATTR-CM patients treated with tafamidis: A single center experience in Turkey - Study ATTREAL

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VYNDAQEL
• Study drug International non-proprietary name (INN) or common name:
  TAFAMIDIS
• Anatomical Therapeutic Chemical (ATC) code:
  (N07XX08) tafamidis

  tafamidis
• Medical condition to be studied:
  Hereditary ATTR amyloid cardiomyopathy
• Additional medical condition(s):
  Transthyretin amyloid cardiomyopathy (ATTR-CM)

Population studied

• Short description of the study population:
  Patients must meet the following inclusion criteria: ; 1) >18 years old at the time of diagnosis; ; ii) diagnosed with hereditary or wild type ATTR-CM confirmed non-invasively (Tc99m PYP bone scintigraphy and/or SPECT-CT) in Samsun Education and Research Hospital – Cardiology Outpatient Clinic between January 2023 – January 2025; ; iii) currently receiving or who have received tafamidis treatment for ATTR-CM; ; iv) Availability of complete medical records, including baseline clinical characteristics, treatment outcomes, and follow-up data from electronic health record systems of hospital or physical patient files. Patients will be excluded if participated in studies involving investigational drugs within 24 months before the index date.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This is a single-center, retrospective, non-interventional cohort study. Study data will be entered in CRF from individual patient medical records maintained in a single center in Turkey.
• Main study objective:
  To describe the rate of hospitalizations and emergency admissions due to chronic heart failure in the patients treated with Tafamidis ;
• Setting:
  One centre involved in the diagnosis and management of patients affected by ATTR-CM will participate in the study. This Centre is selected according to their clinical and research expertise, in addition to the number of patients they are used to routinely caring for. ; A clinical research organization (CRO) on behalf of Pfizer will support the regulatory and administrative procedures to get authorization and the operations at Centre needed for data collection. ; The site Study Team, including the Principal Investigator and additional identified personnel (eg, research nurse, clinical study manager) will be trained on the protocol and planned study procedures, in addition to the use of the study-specific eCRF. ; Original data, routinely collected by means of specific tools (eg, paper charts, electronic charts,) will be transferred to the eCRF by the Study Team in site. ;