ArticleJMIR research protocols2025
Real-World Characteristics and Treatment Patterns of Patients With Transthyretin Amyloid Cardiomyopathy: Protocol for a Multicountry Disease Registry Study.
Article in JMIR research protocols, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06651073 (Real-World Characteristics and Treatment Patterns of Patients With Transthyretin Amyloid Cardiomyopathy), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Real-World Characteristics and Treatment Patterns of Patients With Transthyretin Amyloid Cardiomyopathy (ATTR-CM): A Multi-Country, Non-Interventional, Disease Registry
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4 authors.
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Abstract
backgroundTransthyretin amyloid cardiomyopathy (ATTR-CM) is a systemic amyloidosis disorder with early clinical manifestations similar to other heart conditions, which complicates its diagnosis and management. The disease's insidious nature and its progression to heart failure emphasize the critical need for enhanced recognition and understanding of its clinical landscape.
objectiveThis study aimed to understand the natural history and current treatment patterns for managing ATTR-CM in a diverse Asian cohort from Taiwan, Hong Kong, and Malaysia.
methodsThis study is a multicenter, noninterventional disease registry that plans to enroll patients diagnosed with ATTR-CM across approximately 17 sites in Taiwan, Hong Kong, and Malaysia. Almost 350 patients with a documented diagnosis of ATTR‑CM after June 1, 2019, will be enrolled in the study. Deceased patients will be enrolled without the need for consent in accordance with applicable regulations. Their data will be gathered retrospectively through a 1-time review of their medical records, where permissible. Data related to clinical characteristics, treatment, and outcomes will be collected for each patient during the routine clinical practice while adhering to local standards of care. The end of data collection is planned for at least 12 months after the end of the enrollment period.
resultsAs of March 16, 2025, ethical approvals for this study have been obtained or are under review at multiple sites across Taiwan, Hong Kong, and Malaysia. The study commenced on October 1, 2024, with the first participant's first visit and so far, 59 patients have been recruited: 35 from National Taiwan University Hospital (Taiwan), 13 from Taipei Veterans General Hospital (Taiwan), 2 from China Medical University Hospital (Taiwan), 2 from Sarawak Heart Center (Malaysia), and 7 from Queen Mary Hospital (Hong Kong). An interim report is scheduled for completion by December 31, 2025. The end of data collection, marked by the last participant's visit, is planned for October 1, 2027, and the final study report is expected to be finalized by June 1, 2028. Once established, the database will serve as a comprehensive resource for analyzing baseline characteristics, treatment patterns, and outcomes in patients with ATTR-CM from diverse health care systems.
conclusionsThis research will aid in understanding the demographic, clinical, and therapeutic patterns of ATTR-CM in Taiwan, Hong Kong, and Malaysia. This registry may influence advancements in early detection, diagnosis, and tailored treatment strategies in ATTR-CM.
trial registrationClinicalTrials.gov NCT06651073; https://clinicaltrials.gov/study/NCT06651073. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71314.
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