Condition: Bicuspid Aortic Valve · Sponsor: Yonsei University
This study is to elucidate the impact of germline mutations and clonal hematopoiesis (CHIP) on the progression of early aortic valve calcification in patients with bicuspid aortic valves. The study will be conducted over a recruitment period of one year and a follow-up observation period of two years. Considering a 2-year event rate and a 33% occurrence rate of clonal hematopoiesis, each group requires a minimum of 102 participants. Accounting for a 15% dropout rate, a total of 120 participants are needed for each group (type I error (α) = 5%, type II error (β) = 20%). Therefore, the total study population, including patients with normal aortic valve function, is set at 240 participants.
This description comes directly from the study's public registry record.
Iksung Cho · 82-2-2228-8442 · iksungcho@yuhs.ac
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| Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine | Seoul, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06153407