The China Valvular Heart Disease Study (China-VHD)

China Registry and Cohort Study of Valvular Heart Disease in Adults

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.

Study Overview

• Status: Completed
• Conditions: Valvular Heart Disease

• Study Type: Observational
• Enrollment (Actual): 13917

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients over 60 years old with significant VHD

Description

Inclusion Criteria:

• patients over 60 years old meet one of the following conditions.

  1. 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,
  2. or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  3. or diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	2years

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: yongjian wu, doctor, Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences; Principal Investigator: haiyan xu, doctor, Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 2017-I2M-3-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No