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Completed

NCT Number: NCT07510035

Prevalence and Influencing Factors of Frailty in 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?

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiufang Hong

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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")

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Zhejiang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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