China Senile Valvular Heart Disease Cohort Study

NCT ID: NCT02865798

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Heart Valve Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fuwai hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

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

Role: CONTACT

fuwaihospital@hotmail.com

0086-10-88396780

Facility Contacts

Yongjian Wu, M.D, Ph.D

Role: primary

fuwaihospital@hotmail.com

0086-10-88396780

References

Zhao Q, Xu H, Liu Q, Ye Y, Zhang B, Li Z, Gao R, Wu Y. Therapeutic Decision-Making and Outcomes in Elderly Patients With Severe Symptomatic Aortic Stenosis: Prognostic Implications of Elderly Patients' Initial Decisions. Front Cardiovasc Med. 2021 Jul 26;8:696763. doi: 10.3389/fcvm.2021.696763. eCollection 2021.

Reference Type: DERIVED

PMID: 34381825 (View on PubMed)

Other Identifiers

VHD-20160805

Identifier Type: -

Identifier Source: org_study_id