Tokyo, April 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061396) titled 'Retrospective Observational Study on the Incidence and Treatment Course of Arrhythmias and Conduction Disturbances in Patients with Cardiac Amyloidosis in Shimane University Hospital' on April 27.
Study Type:
Observational
Primary Sponsor:
Institute - Shimane University Faculty of Medicine
Condition:
Condition - Cardiac Amyloidosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The present study aims to elucidate the characteristics of arrhythmias (tachyarrhythmias and bradyarrhythmias) and conduction disturbances occurring in patients with cardiac amyloidosis, and to retrospectively evaluate the clinical course before and after the initiation of disease-modifying therapies, thereby providing insights to inform future management of cardiac amyloidosis.
Basic objectives2 - Others
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients diagnosed with cardiac amyloidosis at Shimane University Hospital between January 1, 2020 and January 31, 2026.
2. Patients with confirmed AL or ATTR amyloidosis.
3. Patients who received or were scheduled to receive disease-modifying therapy, including tafamidis, acoramidis, or vutrisiran.
Key exclusion criteria - Patients with concomitant cardiac diseases other than cardiac amyloidosis, such as ischemic heart disease or valvular disease, in whom arrhythmias or conduction disturbances are judged to be clearly attributable to causes other than cardiac amyloidosis.
Target Size - 70
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 31 Day
Anticipated trial start date - 2026 Year 05 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070245
Disclaimer: Curated by HT Syndication.
