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ATTR-CM: A Multi-country, Non-interventional Disease Registry
Sponsor: Pfizer
Summary
This study is a multi-center, non-interventional, disease registry to characterize the natural history of ATTR-CM and treatment patterns in clinically diagnosed ATTR-CM patients. Data will be collected in the course of routine clinical practice or following local standard practice guidelines. No procedures or treatments will be mandated by this study, patients will receive usual clinical care. The patient population will include all adult patients with a confirmed diagnosis of ATTR-CM after 01 June 2019 and who meet eligibility criteria. The index date of each patient will be the date of the first documented ATTR-CM diagnosis. The observation period for each patient will range from the index date to whichever occurs first of death, patient withdrawal of consent, loss to follow-up, or end of data collection. The end of data collection (ie, the end of study) is planned for 12 months after the end of the enrollment period. As this study is descriptive in nature with no hypothesis testing, the study size will be based on the number of eligible ATTR-CM cases identified in the medical records and meeting the eligibility criteria. Approximately 350 patients diagnosed with ATTR-CM across approximately 17 sites in Taiwan, Hong Kong, and Malaysia are planned to be enrolled.
Official title: Real-World Characteristics and Treatment Patterns of Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM): A Multi-Country, Non-Interventional, Disease Registry
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
350
Start Date
2024-10-01
Completion Date
2028-04-28
Last Updated
2026-08-26
Healthy Volunteers
No
Conditions
Interventions
Observational
There is no intervention involved in the study. It is purely observational.
Locations (17)
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Kwai Chung, Hong Kong
Queen Mary Hospital
Pok Fu Lam, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Institut Jantung Negara
Kuala Lumpur, Malaysia
Hospital Serdang
Kuala Selangor, Malaysia
Sarawak Heart Centre
Sarawak, Malaysia
Taichung Veterans General Hospital
Taichung, Taipei, Taiwan
China Medical University Hospital
Taichung, Taiwan R O C, Taiwan
Chang Gung Memorial Hospital, Linkou
Gueishan Township, Taoyuan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Chi Mei Medical Center
Tainan, Taiwan
National Taiwan University
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan