The China Valvular Heart Disease Study

NCT03484806 | Completed DMC

• 1 other identifier: 2017-I2M-3-002
• Study Type: observational
• Target: 13,917
• Locations: 1 country
• Sites: 1

Brief Summary

This is a observational、multicenter, prospective cohort study for adults with significant VHD. The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with VHD；also to set up registration system of adult VHD in China, to build a database of Chinese adult VHD, to establish a web-based international standard data acquisition system for VHD and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of adult VHD.

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  2years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients over 60 years old with significant VHD

You may qualify if:

• patients over 60 years old meet one of the following conditions.
• moderate or above valvular heart disease as defined by echocardiography: （1）aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, （2）aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （3）mitral stenosis, moderate or above, or valve area ≤1.5cm2, （4）mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （5）tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, （6）tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, （7）pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec, （8）pulmonic regurgitation, moderate or above,
• or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
• or diagnosis of endocarditis as assessed by Duke criteria.

You may not qualify if:

• Patients cannot be followed up for any reasons. Patients have been enrolled in this study.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (2)

• Hu X, Ye Y, Li Z, Liu Q, Zhao Z, Zhou Z, Wang W, Yu Z, Zhang H, Duan Z, Wang B, Zhang B, Lv J, Guo S, Zhao Y, Gao R, Xu H, Wu Y; China-VHD Study Collaborators. Primary regional disparities in clinical characteristics, treatments, and outcomes of a typically designed study of valvular heart disease at 46 tertiary hospitals in China: Insights from the China-VHD Study. Chin Med J (Engl). 2025 Apr 20;138(8):937-946. doi: 10.1097/CM9.0000000000003570. Epub 2025 Mar 18.

  PMID: 40097371 DERIVED

• Zhao Q, Zhang B, Ye Y, Li Z, Liu Q, Zhao R, Zhao Z, Wang W, Yu Z, Zhang H, Duan Z, Wang B, Lv J, Guo S, Zhao Y, Gao R, Xu H, Wu Y. Prognostic Impact of Left Ventricular Ejection Fraction in Patients With Moderate Aortic Regurgitation: Potential Implications for Treatment Decision-Making. Front Cardiovasc Med. 2022 Jan 17;8:800961. doi: 10.3389/fcvm.2021.800961. eCollection 2021.

  PMID: 35111828 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• yongjian wu, doctor

  Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

  STUDY CHAIR

• haiyan xu, doctor

  Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: coronary heart disease center

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: April 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)