Prospective Observational Cohort Study of Moderate Aortic Valve Disease (NCT06595992) | Clinical Trial Compass
RecruitingNot Applicable
Prospective Observational Cohort Study of Moderate Aortic Valve Disease
China1,000 participantsStarted 2024-09-01
Plain-language summary
The objective of this research is to evaluate and predict the progression of moderate aortic stenosis and regurgitation from clinical characterization, biological, echocardiographic, and computed tomography (CT) et. al. Additionally, try to analyze the potential impact of device or drug therapy on the progression of the conditions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All cause mortality
Timeframe: 1-year, 3-year, and 5-year at follow-up
2
Re-hospitalization related to heart failure.
Timeframe: 1-year, 3-year, and 5-year at follow-up
3
Aortic valve replacement
Timeframe: 1-year, 3-year, and 5-year at follow-up
4
Stroke
Timeframe: 1-year, 3-year, and 5-year at follow-up
Trial details
NCT IDNCT06595992
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University