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FrailtyNCT05014750

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

An observational study of Frailty and Elderly, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Elderly, Valvular Heart Disease
What is being tested?
None intervention
How many people
300 participants
Where
1 siteChina
Study dates
1 Sep 2021to 31 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: elderly patients with valvular heart disease

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Zhiyun Shen

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
None intervention
Medical subject headings
Frailty, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None interventionOther

    There is no intervention included in this study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    All-cause death

    Measured: One year after discharge

  2. Falls

    Falls

    Measured: One year after discharge

  3. Rehospitalization

    Unplanned rehospitalization

    Measured: One year after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start1 Sep 2021
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion31 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014750
Sponsor's protocol ID
Frailty Study 01
Status last verified
Aug 2021
First submitted
10 Aug 2021
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Elderly, run by Shanghai Zhongshan Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zhiyun Shen, Master (8618317089276, shen.zhiyun@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: One year after discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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