Aortic Valve DiseaseARISTOTLENCT06069232
Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction
An observational study of Aortic Valve Disease, run by Sun Yat-sen University at 7 sites in China.
Trial summary
This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Aortic Valve Disease
- How many people
- 2,000 participants
- Where
- 7 sitesChina
- Study dates
- 1 Mar 2021to 1 Mar 2028
- 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 to 100 years
- All sexes
- Adult, Older adult
Study population: The participant included in this study were patients with aortic valve disease diagnosed during hospitalization, and these patients were followed up for a long time after discharge.
Who may be able to join
- age ≥ 18
- diagnosed as aortic valve disease
Who cannot join
- aortic valve replacement at baseline
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
xiaodong zhuang, PhD, +86 13760755035, zhuangxd3@mail.sysu.edu.cn
- Recruiting
Third Affiliated Hospital, Sun Yat-Sun University
Guangzhou, Guangdong, 510000
zhuoshan Huang, PhD, +86 13728059476, huangzhsh@mail.sysu.edu.cn
- Recruiting
Jieyang People's Hospital
Jieyang, Guangdong, 522000
Mingwei Xu, PhD, 13828186368, versy@163.com
- Recruiting
Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Jilin Li, PhD, +86 13592852807, lijilin@126.com
- Recruiting
Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, 518000
jianwen liang, PhD, +86 13688847419, liangjw39@mail.sysu.edu.cn
- Recruiting
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Jianying Chen, PhD, +86 13828223032, jychen271@126.com
- Recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528400
li Feng, PhD, +86 13902593410, lifengdoc@126.com
About this study
Official title: Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)
This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.
- Conditions
- Aortic Valve Disease
- Keywords
- aortic stenosis, aortic valve insufficiency, risk factor, prediction model
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
death caused by any cause
Measured: from baseline to death or end of follow-up
Secondary outcomes (2)
Cardiovascular death
Death caused by cardiac causes
Measured: from baseline to death or end of follow-up
Aortic valve replacement
Transcatheter aortic valve replacement or surgical aortic valve replacement
Measured: from baseline to aortic valve replacement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Mar 2021
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, Second Affiliated Hospital of Shantou University Medical College, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Responsible party
- Principal investigator, Xiao-dong Zhuang, Sun Yat-sen University
- Investigators
- xiaodong zhuang, PhD, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069232
- Sponsor's protocol ID
- ARISTOTLE Study
- Acronym
- ARISTOTLE
- Status last verified
- Oct 2023
- First submitted
- 1 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cai X, Hu D, Yan B, Chen J, Li W, Lin Y, Lin R, Ye J, Su J, Tong S, Huang X, Xie B, Zhuang X, Chen J, Li J. Evaluation of EuroSCORE II to Determine the Prognosis of Patients With Moderate-To-Severe Aortic Stenosis: A Long-Term Retrospective Study. Rev Cardiovasc Med. 2026 Feb 4;27(2):42757. doi: 10.31083/RCM42757. eCollection 2026 Feb.
PubMed 41789337Guo Z, Xiong Z, Zhang W, Chen G, Xie M, Zhou Z, Zhang S, Liu M, Li J, Liao X, Zhuang X. Association between cholesterol, high-density lipoprotein, and glucose index and risks of cardiovascular and all-cause mortality in patients with calcific aortic valve stenosis: the ARISTOTLE cohort study. Cardiovasc Diabetol. 2025 Oct 11;24(1):393. doi: 10.1186/s12933-025-02906-2.
PubMed 41076530Li B, Zhang S, Xu C, Huang M, Xiong Z, Hui Z, Liao X, Li J, Chen J, Zhuang X. Association Between the Malnutrition Status and All-Cause Mortality in Patients With Moderate and Severe Aortic Stenosis: A Prospective Cohort Study. J Am Heart Assoc. 2025 Feb 4;14(3):e037086. doi: 10.1161/JAHA.124.037086. Epub 2025 Feb 3.
PubMed 39895526Guo Z, Xiong Z, He L, Zhang S, Xu X, Chen G, Xie M, Zhang W, Hui Z, Li J, Liao X, Zhuang X. Association between triglyceride-glucose-body mass index and risk of aortic stenosis progression in patients with non-severe aortic stenosis: a retrospective cohort study. Cardiovasc Diabetol. 2025 Jan 29;24(1):46. doi: 10.1186/s12933-025-02579-x.
PubMed 39881345
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)
- ClinicalTrials.gov ID
- NCT06069232
- Acronym / sponsor ID
- ARISTOTLE / ARISTOTLE Study
- Conditions
- Aortic Valve Disease
- Keywords
- aortic stenosis, aortic valve insufficiency, risk factor, prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, Second Affiliated Hospital of Shantou University Medical College, Eighth Affiliated Hospital, Sun Yat-sen University, Zhongshan People's Hospital, Guangdong, China, Jieyang People's Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 5 Oct 2023 (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.
This study is a multicenter cohort study including patients diagnosed with aortic valve disease during hospitalization, including aortic insufficiency and aortic valve stenosis. The primary outcome of the study was all-cause death, and the secondary outcome was cardiovascular events. Through follow-up observation, the prognostic risk factors of patients with aortic disease were evaluated, and a prognostic model was constructed to guide clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The participant included in this study were patients with aortic valve disease diagnosed during hospitalization, and these patients were followed up for a long time after discharge.
Key inclusion criteria (2 listed)
- age ≥ 18
- diagnosed as aortic valve disease
Key exclusion criteria (1 listed)
- aortic valve replacement at baseline
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: from baseline to death or end of follow-up
death caused by any cause
2 secondary outcomes
Cardiovascular death
Time frame: from baseline to death or end of follow-up
Aortic valve replacement
Time frame: from baseline to aortic valve replacement
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 12 Oct 2023.
- Derived from this study: PubMed 41789337Cai X, Hu D, Yan B, Chen J, Li W, Lin Y, Lin R, Ye J, Su J, Tong S, Huang X, Xie B, Zhuang X, Chen J, Li J. Evaluation of EuroSCORE II to Determine the Prognosis of Patients With Moderate-To-Severe Aortic Stenosis: A Long-Term Retrospective Study. Rev Cardiovasc Med. 2026 Feb 4;27(2):42757. doi: 10.31083/RCM42757. eCollection 2026 Feb.
- Derived from this study: PubMed 41076530Guo Z, Xiong Z, Zhang W, Chen G, Xie M, Zhou Z, Zhang S, Liu M, Li J, Liao X, Zhuang X. Association between cholesterol, high-density lipoprotein, and glucose index and risks of cardiovascular and all-cause mortality in patients with calcific aortic valve stenosis: the ARISTOTLE cohort study. Cardiovasc Diabetol. 2025 Oct 11;24(1):393. doi: 10.1186/s12933-025-02906-2.
- Derived from this study: PubMed 39895526Li B, Zhang S, Xu C, Huang M, Xiong Z, Hui Z, Liao X, Li J, Chen J, Zhuang X. Association Between the Malnutrition Status and All-Cause Mortality in Patients With Moderate and Severe Aortic Stenosis: A Prospective Cohort Study. J Am Heart Assoc. 2025 Feb 4;14(3):e037086. doi: 10.1161/JAHA.124.037086. Epub 2025 Feb 3.
- Derived from this study: PubMed 39881345Guo Z, Xiong Z, He L, Zhang S, Xu X, Chen G, Xie M, Zhang W, Hui Z, Li J, Liao X, Zhuang X. Association between triglyceride-glucose-body mass index and risk of aortic stenosis progression in patients with non-severe aortic stenosis: a retrospective cohort study. Cardiovasc Diabetol. 2025 Jan 29;24(1):46. doi: 10.1186/s12933-025-02579-x.
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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.
xiaodong zhuang, PhD principal investigator
First Affiliated Hospital, Sun Yat-Sen University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease, run by Sun Yat-sen University at 7 sites 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 2 inclusion and 1 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 xiaodong zhuang, PhD (+86 13760755035, zhuangxd3@mail.sysu.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: from baseline to death or end of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06069232, which also lists 4 linked publications.
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 12 Oct 2023.