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Recruiting NCT06069232

Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction

Observational Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aortic Valve Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Aortic Valve Diseases RISk facTOr assessmenT and Prognosis modeL Construction (ARISTOTLE)

Overview

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.

Primary outcome measures

  • all-cause mortality [Time frame: from baseline to death or end of follow-up]
Secondary outcome measures (2)
  • Cardiovascular death [Time frame: from baseline to death or end of follow-up]
  • Aortic valve replacement [Time frame: from baseline to aortic valve replacement]

Eligibility criteria

Inclusion criteria

  • age ≥ 18
  • diagnosed as aortic valve disease

Exclusion criteria

  • aortic valve replacement at baseline

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 7 centers
  • First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
  • Third Affiliated Hospital, Sun Yat-Sun University — Guangzhou
  • Jieyang People's Hospital — Jieyang
  • Second Affiliated Hospital of Shantou University Medical College — Shantou
  • Eighth Affiliated Hospital, Sun Yat-Sen University — Shenzhen
  • Affiliated Hospital of Guangdong Medical University — Zhanjiang
  • Zhongshan People's Hospital — Zhongshan

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. PMID 41789337
  • Guo 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. PMID 41076530
  • Li 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. PMID 39895526
  • Guo 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. PMID 39881345

Identifiers

NCT: NCT06069232 · ARISTOTLE Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗