Prevalence and Influencing Factors of Frailty in Elderly Patients With Heart Failure

April 2, 2026 updated by: Xiufang Hong, Zhejiang Hospital

A Cross-Sectional Observational Study：Prevalence and Associated Factors of Frailty in Hospitalized Elderly Patients With Heart Failure

The goal of this observational study is to investigate the prevalence and associated factors of frailty in hospitalized elderly patients with heart failure. The main questions it aims to answer are:(1) To clarify differences in demographic characteristics and test results (including CGA, BNP, and echocardiography) among different frail populations (2) What demographic, clinical, and geriatric assessment factors are independently associated with frailty in elderly patients with heart failure?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Xiufang Hong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of hospitalized patients aged ≥60 years with a confirmed diagnosis of heart failure, admitted to the Geriatrics Department of Zhejiang Hospital between January 2023 and December 2023.

Description

Inclusion Criteria:

  1. Age≥60 years
  2. Patients with complete data（Patients who have completed the comprehensive geriatric assessment,BNP testing, electrocardiogram and echocardiography).
  3. Patients meeting the diagnostic criteria for heart failure (as defined in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024")

Exclusion Criteria:

  1. Patients with incomplete data
  2. Patients with severe physical or cognitive impairments that prevent them from completing the assessment.
  3. Acute Infections or cerebrovascular diseases
  4. Terminal illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Non-frail Group
Participants with a Clinical Frailty Scale (CFS) score ranging from 0 to 4.
Moderate Frailty Group
Participants with a Clinical Frailty Scale (CFS) score ranging from 5 to 6.
Severe Frailty Group
Participants with a Clinical Frailty Scale （CFS） score of 7

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical Frail Scale (CFS) score
Time Frame: Baseline
The CFS is assessed through clinical judgment based on a patient's functional status, mobility, activity tolerance, comorbidities, and cognitive function in the preceding two weeks. The scale classifies patients into nine levels based on their degree of frailty: 1 - Very Fit, 2 - Well, 3 - Managing Well, 4 - Vulnerable, 5 - Mildly Frail, 6 - Moderately Frail, 7 - Severely Frail, 8 - Very Severely Frail, and 9 - Terminally Ill. The higher the CFS score, the greater the degree of frailty. Excluding those with scores of 8-9, patients with scores of 0-4 are classified into the non-frail group, while those with scores of 5 or higher are classified into the frail group. Frailty Severity Grading Criteria: Clinical Frailty Scale (CFS) score: non-frail (CFS 0-4), moderate frailty (CFS 5-6), and severe frailty (CFS 7).
Baseline
brain natriuretic peptide (BNP)
Time Frame: Baseline
Assessed using a blood sample analyzed by an immunoassay. This biomarker reflects ventricular wall stress and is widely used for diagnosing and monitoring heart failure. BNP levels are reported in ng/L. According to clinical guidelines, a BNP <100 ng/L is considered normal in untreated patients; levels >400 ng/L are strongly suggestive of heart failure, while values between 100 and 400 ng/L are considered intermediate and should be interpreted in the clinical context. Higher BNP levels indicate greater cardiac stress and correlate with worse outcomes.
Baseline
left ventricular ejection fraction (LVEF) value
Time Frame: Baseline
Assessed using echocardiography (transthoracic echocardiography is the standard method), or alternatively by cardiac magnetic resonance imaging or nuclear imaging. This imaging parameter quantifies the percentage of blood ejected from the left ventricle during systole and is the primary measure of systolic function. LVEF is reported as a percentage (%). According to clinical guidelines, a normal LVEF is ≥50%; a mildly reduced LVEF is 40-49%; a moderately reduced LVEF is 30-39%; and a severely reduced LVEF is <30%. Lower LVEF values indicate worse systolic dysfunction and are associated with increased risk of heart failure and adverse outcomes.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
body mass index (BMI)
Time Frame: Baseline
Calculated from measured height (meters) and weight (kilograms) using the formula: weight (kg) / [height (m)]2. Unit: kg/m2.
Baseline
activities of daily living (ADL) score
Time Frame: Baseline
Assessed using the Barthel Index. This scale evaluates ten activities: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair/bed transfer, ambulation, and stair climbing. The Activities of Daily Living (ADL) scale based on the Barthel Index score ranges from 0 to 100, with higher scores indicate greater independence.
Baseline
instrumental activities of daily living (IADL) score
Time Frame: Baseline
This scale evaluates evaluates eight domains of function: ability to use a telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to handle finances. The total score ranges from 0 (low function, dependent) to 8 (high function, independent) . A higher score on the IADL scale indicates a greater level of independence in performing these instrumental activities of daily living.
Baseline
short physical performance battery (SPPB) score
Time Frame: Baseline
Comprises three components: balance tests (side-by-side, semi-tandem, and tandem stands), 4-meter walk speed test, and five times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score ranging from 0 to 12. The Short Physical Performance Battery (SPPB) score ranges from 0 to 12 and higher scores reflect better lower extremity function.
Baseline
performance-oriented mobility assessment (POMA) score
Time Frame: Baseline
Assessed using the Tinetti Balance and Gait Evaluation. The scale consists of a balance section (9 items, max 16 points) and a gait section (7 items, max 12 points). Total scores range from 0 to 28, with higher scores indicating better balance and gait, and lower fall risk.
Baseline
mini nutritional assessment-short form(MNA-SF) score
Time Frame: Baseline
Assessed using the Mini Nutritional Assessment-Short Form. This 6-item tool screens for malnutrition risk by evaluating weight loss, food intake, mobility, psychological stress, body mass index, and disease. Total scores range from 0 to 14, with scores ≤7 indicating malnutrition, 8-11 indicating at risk of malnutrition, and ≥12 indicating normal nutritional status. The Mini Nutritional Assessment-Short Form (MNA-SF) score ranges from 0 to 14, with higher scores indicating better nutritional status.
Baseline
grip strength
Time Frame: Baseline
Measured using a handheld electronic dynamometer. The participant is seated or standing with the elbow flexed at 90°, forearm and wrist in a neutral position. Maximum force is applied with the dominant hand. The best of two attempts is recorded. Unit: kilograms (kg).
Baseline
skeletal muscle mass index (SMI)
Time Frame: Baseline
Assessed using bioelectrical impedance analysis (BIA) with the InBody device. This method calculates the skeletal muscle mass index (SMI) as appendicular skeletal muscle mass (ASM) divided by height squared (kg/m²). SMI values are sex-specific; according to the Asian Working Group for Sarcopenia (AWGS) 2019 criteria, SMI <7.0 kg/m² for men and <5.4 kg/m² for women indicates low muscle mass. When low muscle mass is accompanied by low muscle strength and/or low physical performance, the diagnosis is sarcopenia or severe sarcopenia. The SMI is reported in kg/m², with lower values reflecting lower relative skeletal muscle mass.
Baseline
dominant calf circumference
Time Frame: Baseline
Assessed using the dominant calf circumference measured with a non-elastic tape. This simple anthropometric indicator screens for low muscle mass by measuring the maximum circumference of the calf, typically on the dominant leg (or the leg with the larger circumference). Values are reported in centimeters. According to the Asian Working Group for Sarcopenia (AWGS) criteria, calf circumference <34 cm in men and <33 cm in women indicates low muscle mass, which is suggestive of sarcopenia when combined with low muscle strength or poor physical performance. Higher calf circumference values reflect greater skeletal muscle mass relative to the lower limb.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZJHIRB-2026-036K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) that underlie the results reported in the primary publication (including baseline characteristics, outcome measures, and analysis data sets) will be made available upon reasonable request to the corresponding author, beginning 9 months after article publication and ending 5 years thereafter. Proposals for data use will be reviewed by the study investigators. Requestors will need to sign a data access agreement specifying the intended use of the data, commitment to using it only for the agreed purpose, and agreement not to attempt to re-identify participants.

IPD Sharing Time Frame

De-identified IPD and supporting documents (study protocol, informed consent form) will become available 9 months after the publication of the primary results manuscript and will remain available for 5 years. Access will be provided upon reasonable request to the corresponding author and require a signed data use agreement.

IPD Sharing Access Criteria

Access will be granted to qualified researchers (affiliated with academic or healthcare institutions) who provide a methodologically sound research proposal approved by the study investigators. Requestors can access de-identified IPD, study protocol, and informed consent form for the purpose of individual participant data meta-analysis, reproducibility checks, or secondary analysis aligned with the original study ethics. Proposals should be submitted to the corresponding author [hongxf_1101@163.com] and require a signed Data Access/Use Agreement that includes commitments to: (1) use data only for the specified purpose; (2) protect data confidentiality; (3) not attempt to re-identify participants; and (4) acknowledge the data source in publications.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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