Clincosm LogoSign in Get a demo

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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06153407
Collaborator
(none)
240
Enrollment
1
Location
59.4
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
    Actual Study Start Date :
    Oct 19, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2027
    Anticipated Study Completion Date :
    Oct 1, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Presence of germline mutation [2 years follow-up]

    2. 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.

    Secondary Outcome Measures

    1. Progression of aortic valve calcification [2 years follow-up]

      Progression of aortic valve calcification measured by computed tomography (AV calcium score) or Echocardiography (Progression of AS/AR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Iksung Cho, Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT06153407
    Other Study ID Numbers:
    • 4-2023-1045
    First Posted:
    Dec 1, 2023
    Last Update Posted:
    Dec 1, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Disease
    Bicuspid Aortic Valve Disease
    Heart Valve Diseases

    Study Results

    No Results Posted as of Dec 1, 2023