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China Senile Valvular Heart Disease Cohort Study

N

National Center for Cardiovascular Diseases

Status

Unknown

Conditions

Heart Valve Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT02865798
VHD-20160805

Details and patient eligibility

About

Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.

Enrollment

4,000 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Hospitalized patients over 60 years old meet one of the following conditions.

  • moderate or above valvular heart disease as defined by echocardiography:

    • aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg,
    • aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
    • mitral stenosis, moderate or above, or valve area ≤2.0cm2,
    • mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
    • tricuspid stenosis, moderate or above, or valve area ≤1.0cm2,
    • tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2,
    • pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec,
    • pulmonic regurgitation, moderate or above,
  • or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),

  • or 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 the near future.
  • Patients have been enrolled in this study.

Trial contacts and locations

1

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Central trial contact

Yongjian Wu, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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