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

Zhongshan Hospital, Fudan University

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.

Study Overview

• Status: Recruiting
• Conditions: Frailty; Elderly; Valvular Heart Disease
• Intervention / Treatment: Other: None intervention

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Zhiyun Shen, Master; Phone Number: 8618317089276; Email: shen.zhiyun@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Zhiyun Shen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

elderly patients with valvular heart disease

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	All-cause death	One year after discharge
Falls	Falls	One year after discharge
Rehospitalization	Unplanned rehospitalization	One year after discharge

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): August 31, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Heart Diseases; Frailty; Heart Valve Diseases
• Other Study ID Numbers: Frailty Study 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No