Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University (VHD-ZJU)

July 14, 2021 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wang Jian-an, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

10000 hospitalized patients over 18 years old with valvular heart disease will be enrolled consecutively

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality and disabling strokes
Time Frame: one year
All-cause mortality and disabling strokes
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for heart failure
Time Frame: one year
Hospitalization for heart failure
one year
Surgical or transcatheter aortic valve replacement
Time Frame: one year
Surgical or transcatheter aortic valve replacement
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Wang Jian-an, MD,PhD, Second Affiliated Hospital Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHZJU CT010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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