NCT06069232

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2021Mar 2028

Study Start

First participant enrolled

March 1, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

7 years

First QC Date

October 1, 2023

Last Update Submit

October 10, 2023

Conditions

Aortic Valve Disease

Keywords

aortic stenosisaortic valve insufficiencyrisk factorprediction model

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    death caused by any cause

    from baseline to death or end of follow-up

Secondary Outcomes (2)

  • Cardiovascular death

    from baseline to death or end of follow-up

  • Aortic valve replacement

    from baseline to aortic valve replacement

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • age ≥ 18
  • diagnosed as aortic valve disease

You may not qualify if:

  • aortic valve replacement at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Third Affiliated Hospital, Sun Yat-Sun University

Guangzhou, Guangdong, 510000, China

RECRUITING

Jieyang People's Hospital

Jieyang, Guangdong, 522000, China

RECRUITING

Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

Eighth Affiliated Hospital, Sun Yat-Sen University

Shenzhen, Guangdong, 518000, China

RECRUITING

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

RECRUITING

Zhongshan People's Hospital

Zhongshan, Guangdong, 528400, China

RECRUITING

Related Publications (2)

  • 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: 41076530DERIVED

  • 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: 39895526DERIVED

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve StenosisAortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • xiaodong zhuang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaodong zhuang, PhD

CONTACT

+86 13760755035zhuangxd3@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2023

First Posted

October 5, 2023

Study Start

March 1, 2021

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations

CN(7)