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Clinical Trials/NCT03011697
NCT03011697
Recruiting
Not Applicable

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country10,000 target enrollmentFebruary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Valvular Heart Disease
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
10000
Locations
1
Primary Endpoint
All-cause mortality and disabling strokes
Status
Recruiting
Last Updated
4 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
December 31, 2027
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Jian'an Wang,MD,PhD

President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

Inclusion Criteria

  • Hospitalized patients over 18 years old meet one of the following conditions.
  • 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,
  • Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  • Diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria

  • Patients cannot be followed up for any reasons.
  • Patients in critical condition may be die in one year.
  • Patients have been enrolled in this study.

Outcomes

Primary Outcomes

All-cause mortality and disabling strokes

Time Frame: one year

All-cause mortality and disabling strokes

Secondary Outcomes

  • Surgical or transcatheter aortic valve replacement(one year)
  • Hospitalization for heart failure(one year)

Study Sites (1)

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