Observing the progression of moderate aortic valve disease
EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06595992
This study looks at how moderate aortic valve disease gets worse over time to help doctors understand what affects its progression and how treatments might help patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06595992 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate and predict the progression of moderate aortic valve stenosis and regurgitation through clinical characterization, biological assessments, echocardiography, and computed tomography. Conducted at the Second Affiliated Hospital of Zhejiang University School of Medicine, the study seeks to understand the factors influencing disease progression and the potential impact of device or drug therapies. The research addresses the lack of consensus on treatment for moderate aortic valve diseases and emphasizes the importance of regular monitoring for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with moderate aortic valve diseases based on echocardiographic criteria.
Not a fit: Patients with severe aortic valve diseases or those requiring imminent surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients with moderate aortic valve disease.
How similar studies have performed: While there is limited consensus on the treatment of moderate aortic valve disease, similar observational studies have provided valuable insights into disease progression, suggesting potential for meaningful findings in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old * Be willing and able to provide informed consent to participate in the study * Patient has moderate aortic valve diseases with echocardiographically derived criteria Exclusion Criteria: * Severe aortic valve diseases with echocardiographically derived criteria or planned cardiac surgery or likely need for surgery within 6 months * Patients who have undergone elective transfemoral transcatheter aortic valve replacement * Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.) * Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit) * Acute pulmonary oedema or cardiogenic shock * The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects * The patient is currently participating in another randomized study
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Jianan Wang, Dorctor — Second Affiliated Hospital of Zhejiang University, School of Medicine
- Study coordinator: Xianbao Liu, Dorctor
- Email: liuxb@zju.edu.cn
- Phone: 086-571-87784705
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.
Conditions: Moderate Aortic Valve Stenosis, Moderate Aortic Valve Regurgitation, Aortic Valve Disease, Aortic Valve Disease Progression, Mortality, Heart Failure