Prospective Observational Cohort Study of Moderate Aortic Valve Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
This study is a prospective observational cohort study aimed at thoroughly investigating the disease progression and influencing factors of patients with moderate aortic valve disease, diagnosed at the Second Affiliated Hospital of Zhejiang University School of Medicine. Aortic valve stenosis and aortic regurgitation are the most common forms of aortic valve disease. According to the 2021 ESC guidelines, moderate aortic stenosis (Moderate AS) is defined as an aortic valve area (AVA) of 1.0-1.5 cm2 on echocardiography (or AVA \<1.0 cm2 with an AVA index of 0.60-0.85 cm2/m2), a peak jet velocity (Vmax) of 3-4 m/s, and/or a mean transvalvular gradient of 20-40 mmHg. Moderate aortic regurgitation (Moderate AR) is defined as a regurgitant fraction between 30% and 50% or an effective regurgitant orifice area between 0.10-0.30 cm2.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
All cause mortality
Time frame
1-year, 3-year, and 5-year at follow-up2
Re-hospitalization related to heart failure.
Time frame
1-year, 3-year, and 5-year at follow-up3
Aortic valve replacement
Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement.
Time frame
1-year, 3-year, and 5-year at follow-up4
Stroke
Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
Time frame
1-year, 3-year, and 5-year at follow-upSecondary outcomes
1
Change in echocardiography examination
valvular mean gradient
Time frame
1-year, 3-year, and 5-year at follow-up2
Change in cardiac CT examination
Calcium volume or calcium volume
Time frame
1-year, 3-year, and 5-year at follow-up3
Change in laboratory examination
elevation of pro-BNP levels
Time frame
1-year, 3-year, and 5-year at follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov