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Clinical Trials in South Korea / NCT06153407
Recruiting Observational

Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve

NCT06153407 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Observational
Started
2023-10-19
Last updated
2023-12-01

Condition(s) studied

Bicuspid Aortic Valve

Study summary

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, CT, MRI) or surgical findings. 2. Early aortic valve calcification group: Patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation. 3. Normal functioning aortic valve group: Patients aged 20-80 with mild or less aortic valve stenosis/regurgitation. 4. Patients who understand the purpose of the study and voluntarily consent to participate. Exclusion Criteria: 1. Patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of less than 6 months. 2. Patients with unclear presence of bicuspid aortic valves. 3. Patients with stage 3 or higher chronic kidney disease. 4. Patients with other inherited cardiac conditions. 5. Patients with cognitive impairment or hemodynamically unstable patients who have difficulty understanding the study content.

Primary outcome measure(s)

  • Presence of germline mutation — 2 years follow-up
  • Clonal hematopoiesis of indeterminate potential (CHIP) mutation — 2 years follow-up
    Clonal hematopoiesis of indeterminate potential (CHIP) is the presence of a clonally expanded hematopoietic stem cell caused by a leukemogenic mutation.

Trial sites (1)

FacilityCityRegionStatus
Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06153407 on ClinicalTrials.gov ↗ ← All trials in South Korea