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

NCT07510035 | Completed

• 1 other identifier: ZJHIRB-2026-036K
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief 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) among different frail populations (2) What demographic, clinical, and geriatric assessment factors are independently associated with frailty in elderly patients with heart failure?

Conditions

Elderly Inpatients; Frail; Heart Failure Hospitalization; CGA

Keywords

elderly inpatients; Frail Elderly people hospitalized; heart failure; clinical geriatric assessment

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Secondary Outcomes (9)

• body mass index (BMI)

  Baseline

• activities of daily living (ADL) score

  Baseline

• instrumental activities of daily living (IADL) score

  Baseline

• short physical performance battery (SPPB) score

  Baseline

• performance-oriented mobility assessment (POMA) score

  Baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Hospital: lead

Study Sites (1)

Xiufang Hong

Hangzhou, Zhejiang, China

Location

Related Publications (12)

• 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.

  PMID: 41068970 BACKGROUND

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

  BACKGROUND

• Matsue Y, Kamiya K, Saito H, et al. Current findings and challenges on frailty, sarcopenia, and cachexia in older patients with heart failure: insights from the FRAGILE-HF study[J].J Cardiol.2025,86(1):1-9.

  BACKGROUND

• 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.

  PMID: 38099896 BACKGROUND

• 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.

  PMID: 40159241 BACKGROUND

• 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.

  PMID: 38291000 BACKGROUND

• 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.

  PMID: 40711891 BACKGROUND

• 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.

  PMID: 40155186 BACKGROUND

• 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.

  PMID: 40977495 BACKGROUND

• 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.

  PMID: 38767446 BACKGROUND

• 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.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 38514328 BACKGROUND

Related Links

• The official website of Zhejiang Hospital

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 3, 2026
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

CN (1)