Moderate Aortic Valve StenosisNCT06595992
Prospective Observational Cohort Study of Moderate Aortic Valve Disease
An observational study of Moderate Aortic Valve Stenosis and Moderate Aortic Valve Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate Aortic Valve Stenosis, Moderate Aortic Valve Regurgitation, Aortic Valve Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Jan 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310000
Xianbao Liu, Dorctor, liuxb@zju.edu.cn
Jian'an Wang, Dorctor
About this study
Official title: EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
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.
Read the detailed description
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 (MG) 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.
While treatment guidelines for patients with severe AS are well-established, there is currently no clear consensus on the treatment of patients with moderate AS, and the subsequent disease progression for these patients remains unclear. Similarly, when the aortic valve shows only moderate regurgitation, surgical treatment is usually not required; the most important aspect is regular monitoring of disease changes, including regular echocardiographic examinations. It is noteworthy that the time span from moderate to severe aortic regurgitation can vary from 1 to 10 years, and the monitoring and early warning mechanisms for potential markers indicating disease deterioration are currently not well developed. The goal of this study is to identify all clinical characterization, biological, echocardiographic, and CT imaging parameters that may increase the risk of disease progression. The confirmation of these parameters will guide future research to develop medical and interventional treatment methods to reduce mortality associated with this disease. Patients participating in this study will undergo outpatient follow-up every 1 year after diagnosis and will undergo electrocardiography, echocardiography, blood analysis, and enhanced CT examinations at 1, 3, and 5 years (plus once if an endpoint event occurs). Through these comprehensive monitoring methods, we expect to more accurately assess changes in the patient\'s condition and provide a scientific basis for clinical decision-making.
- Keywords
- Aortic Valve Disease Progression, Mortality, Heart Failure
- Medical subject headings
- Aortic Valve Disease, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 1-year, 3-year, and 5-year at follow-up
Re-hospitalization related to heart failure.
Measured: 1-year, 3-year, and 5-year at follow-up
Aortic valve replacement
Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement.
Measured: 1-year, 3-year, and 5-year at follow-up
Stroke
Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
Measured: 1-year, 3-year, and 5-year at follow-up
Secondary outcomes (3)
Change in echocardiography examination
valvular mean gradient
Measured: 1-year, 3-year, and 5-year at follow-up
Change in cardiac CT examination
Calcium volume or calcium volume
Measured: 1-year, 3-year, and 5-year at follow-up
Change in laboratory examination
elevation of pro-BNP levels
Measured: 1-year, 3-year, and 5-year at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2024
- Primary completionJan 2034 (estimated)
- Study completionJan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, Dorctor, Principal investigator, Second Affiliated Hospital of Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595992
- Sponsor's protocol ID
- 2024-0357
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVOLUTION: Prospective Observational Cohort Study of Moderate Aortic Valve Disease
- ClinicalTrials.gov ID
- NCT06595992
- Acronym / sponsor ID
- 2024-0357
- Keywords
- Aortic Valve Disease Progression, Mortality, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jan 2034 (estimated)
- Study completion
- Jan 2034 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (MG) 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.
While treatment guidelines for patients with severe AS are well-established, there is currently no clear consensus on the treatment of patients with moderate AS, and the subsequent disease progression for these patients remains unclear. Similarly, when the aortic valve shows only moderate regurgitation, surgical treatment is usually not required; the most important aspect is regular monitoring of disease changes, including regular echocardiographic examinations. It is noteworthy that the time span from moderate to severe aortic regurgitation can vary from 1 to 10 years, and the monitoring and early warning mechanisms for potential markers indicating disease deterioration are currently not well developed. The goal of this study is to identify all clinical characterization, biological, echocardiographic, and CT imaging parameters that may increase the risk of disease progression. The confirmation of these parameters will guide future research to develop medical and interventional treatment methods to reduce mortality associated with this disease. Patients participating in this study will undergo outpatient follow-up every 1 year after diagnosis and will undergo electrocardiography, echocardiography, blood analysis, and enhanced CT examinations at 1, 3, and 5 years (plus once if an endpoint event occurs). Through these comprehensive monitoring methods, we expect to more accurately assess changes in the patient\'s condition and provide a scientific basis for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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 \&amp;amp;lt;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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause mortality
Time frame: 1-year, 3-year, and 5-year at follow-up
Re-hospitalization related to heart failure.
Time frame: 1-year, 3-year, and 5-year at follow-up
Aortic valve replacement
Time frame: 1-year, 3-year, and 5-year at follow-up
Surgical Aortic Valve Replacement or Transcatheter Aortic Valve Replacement.
Stroke
Time frame: 1-year, 3-year, and 5-year at follow-up
Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
3 secondary outcomes
Change in echocardiography examination
Time frame: 1-year, 3-year, and 5-year at follow-up
Change in cardiac CT examination
Time frame: 1-year, 3-year, and 5-year at follow-up
Change in laboratory examination
Time frame: 1-year, 3-year, and 5-year at follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianan Wang, Dorctor principal investigator
Second Affiliated Hospital of Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate Aortic Valve Stenosis and Moderate Aortic Valve Regurgitation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianbao Liu, Dorctor (086-571-87784705, liuxb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 1-year, 3-year, and 5-year at follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.