The China Valvular Heart Disease Study

Completed

• Conditions: Valvular Heart Disease

• Registration Number: NCT03484806
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study Start: 2018-04-01
• Study First Posted: 2018-04-02
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13917

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	2years

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China