The China Valvular Heart Disease Study

Valvular Heart Disease Clinical Trial

— China-VHD  

Official title:

China Registry and Cohort Study of Valvular Heart Disease in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484806
• Other study ID #: 2017-I2M-3-002
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13917
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all-cause mortality		2years