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Elderly InpatientsNCT07510035

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

An observational study of Elderly Inpatients and Frail, run by Zhejiang Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 60 years and older
How many people
298 participants
Where
1 siteChina
Study dates
1 Jan 2023to 31 Dec 2023
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiufang Hong

    Hangzhou, Zhejiang

Other trials in China

About this study

Official title: 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?

Keywords
elderly inpatients, Frail Elderly people hospitalized, heart failure, clinical geriatric assessment
Medical subject headings
Heart Failure

What participants receive

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

Study groups in NCT07510035
Study groupRoleWhat they receive
Non-frail GroupParticipants with a Clinical Frailty Scale (CFS) score ranging from 0 to 4.
Moderate Frailty GroupParticipants with a Clinical Frailty Scale (CFS) score ranging from 5 to 6.
Severe Frailty GroupParticipants with a Clinical Frailty Scale （CFS） score of 7

What is being measured

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

  1. Clinical Frail Scale (CFS) score

    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).

    Measured: Baseline

  2. brain natriuretic peptide (BNP)

    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.

    Measured: Baseline

  3. left ventricular ejection fraction (LVEF) value

    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.

    Measured: Baseline

Secondary outcomes (9)

  1. body mass index (BMI)

    Calculated from measured height (meters) and weight (kilograms) using the formula: weight (kg) / [height (m)]2. Unit: kg/m2.

    Measured: Baseline

  2. activities of daily living (ADL) score

    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.

    Measured: Baseline

  3. instrumental activities of daily living (IADL) score

    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.

    Measured: Baseline

  4. short physical performance battery (SPPB) score

    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.

    Measured: Baseline

  5. performance-oriented mobility assessment (POMA) score

    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.

    Measured: Baseline

  6. mini nutritional assessment-short form(MNA-SF) score

    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.

    Measured: Baseline

  7. grip strength

    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).

    Measured: Baseline

  8. skeletal muscle mass index (SMI)

    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.

    Measured: Baseline

  9. dominant calf circumference

    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.

    Measured: Baseline

Timeline

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

  1. First posted3 Apr 2026
  2. Study start1 Jan 2023
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

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
Cross-sectional
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510035
Sponsor's protocol ID
ZJHIRB-2026-036K
Status last verified
Apr 2026
First submitted
20 Mar 2026
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Yang X, Zhao ZP, Shi Y, Han GY, Xu Y, Li YC, Zhou MG. The evolving burden of heart failure in China: a 34-year subnational analysis of trends and causes from the Global Burden of Disease Study 2023. Mil Med Res. 2025 Oct 9;12(1):65. doi: 10.1186/s40779-025-00650-y.

    PubMed 41068970

  • Leng X. Concepts and practices of geriatric medicine in the United States[J]. Chinese Journal of Practical Internal Medicine, 2011, 31(1): 31-33.

  • Uchida S, Kamiya K, Yamashita M, Noda T, Kagiyama N, Matsue Y. Current findings and challenges on frailty, sarcopenia, and cachexia in older patients with heart failure: insights from the FRAGILE-HF study. J Cardiol. 2026 Jan;87(1):10-16. doi: 10.1016/j.jjcc.2025.05.013. Epub 2025 May 28.

    PubMed 40447042

  • Denfeld QE, Jha SR, Fung E, Jaarsma T, Maurer MS, Reeves GR, Afilalo J, Beerli N, Bellumkonda L, De Geest S, Gorodeski EZ, Joyce E, Kobashigawa J, Mauthner O, McDonagh J, Uchmanowicz I, Dickson VV, Lindenfeld J, Macdonald P. Assessing and managing frailty in advanced heart failure: An International Society for Heart and Lung Transplantation consensus statement. J Heart Lung Transplant. 2023 Nov 29:S1053-2498(23)02028-4. doi: 10.1016/j.healun.2023.09.013. Online ahead of print.

    PubMed 38099896

  • Kitai T, Kohsaka S, Kato T, Kato E, Sato K, Teramoto K, Yaku H, Akiyama E, Ando M, Izumi C, Ide T, Iwasaki YK, Ohno Y, Okumura T, Ozasa N, Kaji S, Kashimura T, Kitaoka H, Kinugasa Y, Kinugawa S, Toda K, Nagai T, Nakamura M, Hikoso S, Minamisawa M, Wakasa S, Anchi Y, Oishi S, Okada A, Obokata M, Kagiyama N, Kato NP, Kohno T, Sato T, Shiraishi Y, Tamaki Y, Tamura Y, Nagao K, Nagatomo Y, Nakamura N, Nochioka K, Nomura A, Nomura S, Horiuchi Y, Mizuno A, Murai R, Inomata T, Kuwahara K, Sakata Y, Tsutsui H, Kinugawa K; Japanese Circulation Society and the Japanese Heart Failure Society Joint Working Group. JCS/JHFS 2025 Guideline on Diagnosis and Treatment of Heart Failure. Circ J. 2025 Jul 25;89(8):1278-1444. doi: 10.1253/circj.CJ-25-0002. Epub 2025 Jun 25. No abstract available.

    PubMed 40159241

  • Lai HY, Huang ST, Anker SD, von Haehling S, Akishita M, Arai H, Chen LK, Hsiao FY. The burden of frailty in heart failure: Prevalence, impacts on clinical outcomes and the role of heart failure medications. J Cachexia Sarcopenia Muscle. 2024 Apr;15(2):660-670. doi: 10.1002/jcsm.13412. Epub 2024 Jan 30.

    PubMed 38291000

  • Kaufmann CC, Ahmed A, Harbich PF, Auer L, Propst L, Weltler P, Burger AL, Zweiker D, Geppert A, Huber K, Jager B. Prognostic impact of frailty at admission and in-hospital changes of frailty status in elderly patients with acute heart failure. Eur J Heart Fail. 2025 Nov;27(11):2501-2511. doi: 10.1002/ejhf.3779. Epub 2025 Jul 25.

    PubMed 40711891

  • Goyal P, Zainul O, Sharma Y, Reich A, Osma P, Lau JD, Massou E, Turchioe M, Russell D, Creber RM, Deaton C. Geriatric Vulnerabilities Among Adults With Heart Failure With Preserved Ejection Fraction: A Cross-Continent Evaluation. JACC Adv. 2025 Mar;4(3):101602. doi: 10.1016/j.jacadv.2025.101602.

    PubMed 40155186

  • Galati G, Germanova O, Dacquino G, Bravo FF, Genovese L, Pedretti RFE. Cardiovascular Diseases Epidemiology and Management in the Elderly and very Elderly. Eur J Prev Cardiol. 2025 Sep 22:zwaf470. doi: 10.1093/eurjpc/zwaf470. Online ahead of print.

    PubMed 40977495

  • Maeda D, Fujimoto Y, Nakade T, Abe T, Ishihara S, Jujo K, Matsue Y. Frailty, Sarcopenia, Cachexia, and Malnutrition in Heart Failure. Korean Circ J. 2024 Jul;54(7):363-381. doi: 10.4070/kcj.2024.0089. Epub 2024 Apr 26.

    PubMed 38767446

  • Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

    PubMed 11253156

  • Chinese Society of Cardiology, Chinese Medical Association; Chinese College of Cardiovascular Physician; Chinese Heart Failure Association of Chinese Medical Doctor Association; Editorial Board of Chinese Journal of Cardiology. [Chinese guidelines for the diagnosis and treatment of heart failure 2024]. Zhonghua Xin Xue Guan Bing Za Zhi. 2024 Mar 24;52(3):235-275. doi: 10.3760/cma.j.cn112148-20231101-00405. Chinese.

    PubMed 38514328

Questions about this trial

What is this clinical trial studying?

An observational study of Elderly Inpatients and Frail, run by Zhejiang 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 4 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: finished, as of the sponsor's last update on 8 Apr 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Frail Scale (CFS) score (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT07510035, which also lists 12 linked publications.

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 8 Apr 2026.

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