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

NCT06153407 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2023-12-01

No results posted yet for this 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.

Conditions

  • Bicuspid Aortic Valve

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Iksung Cho · Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2027-10-31
Completion
2028-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06153407 on ClinicalTrials.gov