Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University

Valvular Heart Disease Clinical Trial

— VHD-ZJU  

Official title:

A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011697
• Other study ID #: SAHZJU CT010
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Liu Xianbao, MD
• Phone: +86-13857173887
• Email: liuxb2009[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Description:

Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular diseases are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification，cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Hospitalized patients over 18 years old meet one of the following conditions.

1. moderate or above valvular heart disease as defined by echocardiography: 1.1 Aortic stenosis, moderate or above, or valve area =1.5cm2, or maximal jet velocity =3.0m/sec, or mean pressure gradient =20mmHg, 1.2 Aortic regurgitation, moderate or above, or jet width =25% of left ventricular outflow tract, or regurgitant volume =30ml/beat, or regurgitant fraction =30%, 1.3 Mitral stenosis, moderate or above, or valve area =2.0cm2, 1.4 Mitral regurgitation, moderate or above, or effective regurgitant orifice =0.2cm2, or regurgitant volume =30ml/beat, or regurgitant fraction =30%, 1.5 Tricuspid stenosis, moderate or above, or valve area =1.0cm2, 1.6 Tricuspid regurgitation, moderate or above, or central jet area =5.0cm2, 1.7 Pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec, 1.8 Pulmonic regurgitation, moderate or above,

2. Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),

3. Diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.

2. Patients in critical condition may be die in one year.

3. 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	2nd Affiliated Hospital, School of Medicine at Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (1)

Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality and disabling strokes	All-cause mortality and disabling strokes	one year
Secondary	Hospitalization for heart failure	Hospitalization for heart failure	one year
Secondary	Surgical or transcatheter aortic valve replacement	Surgical or transcatheter aortic valve replacement	one year

External Links

•   hospital-based survey of patients with severe valvular heart disease in China