Observing the progression of bicuspid aortic valve in Chinese patients
A Cohort Study of Congenital Bicuspid Aortic Valve
This study looks at how bicuspid aortic valve affects young Chinese patients over time to better understand the condition and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06802016 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather comprehensive epidemiological data on congenital bicuspid aortic valve (BAV) in China, where its prevalence may be higher than previously recognized. The study will analyze genetic backgrounds, pathological progression, and imaging characteristics of young patients diagnosed with BAV. Participants aged 14-60 will be monitored over time to understand disease progression and treatment outcomes, contributing to the identification of high-risk individuals. The findings may enhance clinical observation and management of BAV in the Chinese population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14-60 with a definitive diagnosis of bicuspid aortic valve confirmed by imaging.
Not a fit: Patients with rheumatic heart valve disease or other organic valve diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and management of high-risk individuals with bicuspid aortic valve.
How similar studies have performed: While there is limited comprehensive epidemiological data on BAV in China, previous studies have indicated a higher prevalence, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients were aged 14-60 years; * Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.) * Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee. Exclusion Criteria: * Poor patient compliance and inability to complete follow-up visits as required; * Rheumatic heart valve disease, other organic valve disease. * Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics. * Other circumstances that the researcher believes should be excluded.
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin hospital, Shanghai JiaoTong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wenli Zhang, MD
- Email: zwl11929@rjh.com.cn
- Phone: +86 (021)64370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.