Genetic Test Based Risk Prediction of Early Calcific Aortic Valve Disease in Patients With Bicuspid Aortic Valve
Recruiting now
Conditions studied: Bicuspid Aortic Valve
In brief
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.
Key facts
- Study ID
- NCT06153407
- Run by
- Yonsei University
- People needed
- 240
- Starts
- 2023-10-19
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2023-12-01
Who can join
Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with confirmed bicuspid aortic valves based on cardiac imaging (echocardiography, CT, MRI) or surgical findings.
- Early aortic valve calcification group: Patients aged 20-80 with moderate or greater aortic valve stenosis/regurgitation.
- Normal functioning aortic valve group: Patients aged 20-80 with mild or less aortic valve stenosis/regurgitation.
- Patients who understand the purpose of the study and voluntarily consent to participate.
You may not qualify if…
- Patients with malignant neoplastic diseases or other conditions, such as cerebrovascular accidents, which predict survival of less than 6 months.
- Patients with unclear presence of bicuspid aortic valves.
- Patients with stage 3 or higher chronic kidney disease.
- Patients with other inherited cardiac conditions.
- Patients with cognitive impairment or hemodynamically unstable patients who have difficulty understanding the study content.
Where it is running
- Division of Cardiology, Yonsei University Health System, Yonsei University College of Medicine — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.