Heart Valve Diseases Clinical Trial
Official title:
Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease
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.
Status | Not yet recruiting |
Enrollment | 4000 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 60 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
China | Fuwai hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
China National Center for Cardiovascular Diseases | Ministry of Science and Technology of the People´s Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | all cause mortality | one year | No |
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