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

Last updated: November 30, 2023
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Valve Disease

Treatment

N/A

Clinical Study ID

NCT06153407
4-2023-1045
  • Ages 19-80
  • All Genders

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 Criteria

Inclusion

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 greateraortic valve stenosis/regurgitation.
  3. Normal functioning aortic valve group: Patients aged 20-80 with mild or less aorticvalve stenosis/regurgitation.
  4. Patients who understand the purpose of the study and voluntarily consent toparticipate.

Exclusion

Exclusion Criteria:

  1. Patients with malignant neoplastic diseases or other conditions, such ascerebrovascular 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 havedifficulty understanding the study content.

Study Design

Total Participants: 240
Study Start date:
October 19, 2023
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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