Frailty of Elderly With Valvular Heart Disease and the Short Term Adverse Events

Frailty Clinical Trial

Official title:

Zhongshan Hospital, Fudan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014750
• Other study ID #: Frailty Study 01
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Zhiyun Shen, Master
• Phone: 8618317089276
• Email: shen.zhiyun[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite the rapid development of medical and nursing technology, the prognosis of valvular heart disease has been greatly improved. However, compared with young patients, the mortality and adverse event rate of elderly patients with valvular heart disease are still high, surgical complications are more frequent and hospitalization time is longer. The complexity of valvular heart disease and the poor prognosis in the elderly forces us to continue to look for other potential prognostic factors. In addition to the adverse outcomes caused by disease factors, elderly patients with valvular heart disease also have the gradual decline of physiological and psychological reserve function caused by age factors. These adverse outcomes include osteopenia, disability, prolonged hospitalization and even death are all closely related to frailty. Frailty is 'a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes. The essence of frailty is the decline of individual resistance, which eventually leads to the increase of individual brittleness and susceptibility to adverse health outcomes. At present, the research in the field of elderly vulnerable groups of cardiovascular disease in China started late, mostly focusing on the study of pathological mechanism, the introduction of evaluation tools, conceptual analysis and so on. Almost all of the existing studies are about the debilitation status of elderly patients with heart valve disease, and most of them mainly try to find the influencing factors of debilitation from the aspects of patients' physical diseases, ignoring the impact of factors such as the mental health status of the elderly on debilitation, there are few reports of short-term adverse events in elderly patients with valvular heart disease. This study will analyze the influencing factors of the weakness of elderly patients with valvular diseases from the multi-dimensional aspects of demographic data, physical diseases, psychology and society, and track the short-term prognosis of patients with death, fall and unconventional rehospitalization, so as to provide a research basis for relevant research in the future.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age = 65 years;
• Willing to continue to participate in this study;
• Diagnosed as valvular heart disease

Exclusion Criteria:

• suffering from other irreversible serious diseases;
• with severe mental disorders;
• cannot accept frailty assessment due to treatment needs and other factors.

Related Conditions & MeSH terms

• Elderly
• Frailty
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• None intervention
There is no intervention included in this study.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death	All-cause death	One year after discharge
Primary	Falls	Falls	One year after discharge
Primary	Rehospitalization	Unplanned rehospitalization	One year after discharge