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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02865798
Other study ID # VHD-20160805
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 10, 2016
Last updated August 10, 2016
Start date September 2016
Est. completion date December 2017

Study information

Verified date August 2016
Source China National Center for Cardiovascular Diseases
Contact Yongjian Wu, M.D., Ph.D.
Phone 0086-10-88396780
Email fuwaihospital@hotmail.com
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China Fuwai hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary all cause mortality one year No
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