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NCT Number: NCT03011697

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality and disabling strokes

    Time frame: one year

    All-cause mortality and disabling strokes

Secondary outcomes

  1. Hospitalization for heart failure

    Time frame: one year

    Hospitalization for heart failure

  2. Surgical or transcatheter aortic valve replacement

    Time frame: one year

    Surgical or transcatheter aortic valve replacement

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Xianbao, MD

CONTACT

[email protected]

+86-13857173887

Wang Jian-an, MD,PhD

CONTACT

[email protected]

+86-13805786328

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Acronym: VHD-ZJU

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2017
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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