Clinical trial NCT03484806: The China Valvular Heart Disease Study
Official title: China Registry and Cohort Study of Valvular Heart Disease in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2018-04-02
Enrollment: 13917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 60 years old with significant VHD

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.


Eligibility criteria: 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.

Primary outcomes:
measure: all-cause mortality
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
name: yongjian wu, doctor
role: STUDY_CHAIR
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
name: haiyan xu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.