An observational study in Heart Failure, Sarcopenia and Muscle Weakness, sponsored by University of Liverpool. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-05.
Sponsored by University of Liverpool · Observational
In the United Kingdom, heart failure (HF) affects about 900,000 people with 60,000 new cases annually. Up to 60% of people living with HF also experience sarcopenia, known as loss of muscle mass and strength. Sarcopenia contributes significantly to low physical capacity and exercise intolerance and worsens the prognosis of the disease and quality of life.
In comparison to primary sarcopenia (age-related sarcopenia), secondary sarcopenia occurs if other factors, including malignancy or organ failure, are evident in addition to aging. Secondary sarcopenia is highly common in patients with heart failure (Sarc-HF) (prevalence is 35%-69%), and has a significantly negative impact on exercise capacity, weight-adjusted peak maximal oxygen consumption, left ventricular function, and re-hospitalization rates and mortality.
In this integrated study of NHS patients with HF, the investigators aim is to identify the underlying mechanisms of muscle weakness in HF utilizing including body composition, circulating metabolites (metabolic profile), and functional tests for (1) early detection of otherwise subclinical HF, (2) diagnostic assessment of clinically manifest HF-sarcopenia, (3) the risk stratification of subjects with a suspected or confirmed diagnosis, and (4) selection of an appropriate therapeutic intervention.
Investigators aim to understanding the underlying physiological links for secondary sarcopenia in older age and particularly those with heart failure. This links partly can be explained by impaired energy metabolism of amino acids and fatty acid oxidation. This can lead to lower ATP production and deprivation of both skeletal muscle and heart from energy sources, which worsens the sarcopenia in HF.
RESEARCH QUESTION/AIM(S)
Outcomes Descriptive and bioinformatic analysis on associations of multivariate biomarkers including muscle mass and muscle strength from lower and upper body and functional tests, and plasma metabolome and proteome items according to cardiac function and HF status.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 80 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Older men and women with and without HF are targeted following a screening of medical records from the Liverpool Hospital Foundation NHS Trust HF clinic. Our usual practice is to recruit the non-HF controls by community approach.
Inclusion criteria for HF:
Exclusion criteria for HF:
Inclusion criteria for Healthy controls:
Patient diagnosed with heart failure with reduced ejection fraction (HFrEF): EF less than or equal to 40% and heart failure with preserved EF (HFpEF): EF is greater than or equal to 50%.
Diagnostic Test: Dual X Ray Absorptiometry
older people without HF.
Diagnostic Test: Dual X Ray Absorptiometry
* Dual X Ray Absorptiometry in the combination with functional tests * Near-infrared spectroscopy in combination with hand grip strength
Also known as: Near-infrared spectroscopy, Electromyography
Appendicular Lean Mass (kg)
Appendicular lean mass refers to the skeletal muscle mass in the limbs, including the arms and legs. It is a specific component of body composition that is often assessed in research and clinical settings. The term "appendicular" refers to the appendages or limbs of the body. This will be measured via dual x-ray absorptiometry (GE Lunar iDXA).
Time frame: Baseline
Gait Speed (m/s)
Gait speed test (10-meter walking); a physical function test for which the participants' walking speed is measured.
Time frame: Baseline
Handgrip Strength (kg)
A surrogate marker of upper-body strength for which a hand dynamometer (Jamar Hydraulic Hand Dynamometer) will be used for its assessment in both arms.
Time frame: Baseline
Metabolomics
Metabolomics is a branch of omics sciences that involves the comprehensive study of small molecules, known as metabolites, within a biological system. As part of this study blood samples will be analysed using Chromatography Mass Spectrometry (LC/MS).
Time frame: Baseline
Hospital admission due to cardiac event
Number of hospital admissions due to cardiac event for each participant
Time frame: up to 3 years
Short-chain fatty acid count
Faecal concentration of short-chain fatty acids will be assessed via Gas Chromatography Mass Spectrometry (GC/MS); a powerful analytical technique used to analyze and quantify the concentration of various compounds, including Short-chain fatty acid, in biological samples.
Time frame: Baseline
Gut microbiota count
For the assessment of gut microbiota through faecal samples, 16S rRNA-based sequencing will be employed. 16S rRNA-based sequencing is a molecular biology technique used for the analysis of microbial communities, particularly bacteria.
Time frame: Baseline
Dietary Intake (kcal and grams/day)
Food Frequency Questionnaire (FFQ- EPIC-Norfolk) will be used to evaluate the daily energy and macro/micronutrient intake of each participant. Data from FFQ will be analysed FETA, which is an open source, cross-platform tool that processes dietary data from the food frequency questionnaire used by the European Prospective Investigation into Cancer and Nutrition Norfolk (EPIC-Norfolk) and automatically generates a spreadsheet containing energy, nutrient and food group intakes.
Time frame: Baseline
Quality of Life (score)
The SarQoL questionnaire is a patient-reported outcome measure specific to sarcopenia in aged people. The SarQoL® questionnaire consists of 22 questions incorporating 55 items that fall into seven domains of health-related quality of life (HRQoL). These domains are "Physical and Mental Health," "Locomotion," "Body Composition," "Functionality," "Activities of Daily Living," "Leisure activities," and "Fears," and it takes 10 min to complete. Each domain is scored from 0 to 100, and an overall score is calculated obtained the official scoring algorithm from the developers of the SarQoL® questionnaire.
Time frame: Baseline
Physical Activity level
International Physical Activity Questionnaire (IPAQ) (physical activity levels of each participant)
Time frame: Baseline
Insomnia (score)
Responses can range from 0 to 4, where higher scores indicate more acute symptoms of insomnia. Scores are tallied and can be compared both to scores obtained at a different phase of treatment and to the scores of other individuals. A total score of 0-7 indicates "no clinically significant insomnia," 8-14 means "sub-threshold insomnia," 15-21 is "clinical insomnia (moderate severity)," and 22-28 means "clinical insomnia (severe).
Time frame: Baseline
Malnutrition (score)
Mini Nutritional Assessment (malnutrition status of each participant). Individuals will be divided in 3 groups using threshold values of \<17 for 'malnourished', 17-23.5 for 'at risk of malnutrition' and ≥ 24 for 'normal nutritional status', with a maximum total score of 30 point.
Time frame: Baseline
Sleep Quality (score)
Pittsburgh Sleep Quality Index (PSQI) (sleep quality status of each participant). The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Time frame: Baseline
SARC-F (score)
SARC-F scale scores range from 0 to 10 (i.e. 0-2 points for each component; 0 = best to 10 = worst) and were dichotomised to represent symptomatic (4+) vs. healthy (0-3) status.
Time frame: Baseline
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Liverpool