Heart FailureNCT06217640
Multivariate Biomarker Study for Sarcopenia in Heart Failure
An observational study of Heart Failure and Sarcopenia, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Sarcopenia, Muscle Weakness
- What is being tested?
- Dual X Ray Absorptiometry
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Clinically diagnosed HF regardless of ejection fraction rate (both HFrEF and HFpEF).
- Age 50 years and older.
- BMI more than 18 and less than 30 kg/m^2.
- Must be on optimal medical treatment for three months prior to inclusion.
- Do not have contraindications to providing a blood sample.
- Sufficient mental capacity to consent as determined by the researchers.
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- Able to walk with or without a walker for at least 16 m.
- No objection to the researchers contacting their general practitioner and neurologist.
- No history of chronic disease and will be screened for hypertension.
- BMI more than 18 and less than 30 kg/m^2.
- Although other cardiovascular conditions will be exclusionary, treated hypercholesterolemia and controlled hypertension will be allowed in the healthy group to allow the representation of elderly subjects within this cohort.
Who cannot join
- Receiving treatment with antibiotics, probiotics, or fish oil during the last 3 months prior to inclusion.
- Major comorbidities (i.e., cancer, Alzheimer's, type 2 diabetes, chronic kidney disease).
- Treatment with immunosuppressive drugs.
- Concurrent infections, or bowel disease.
- Patients who had received cardiac resynchronization therapy during the past 6 months will not be included.
- Participants must also not be on any other clinical trial during the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, L97AL
About this study
Official title: Towards Diagnosis of Secondary Sarcopenia as a Comorbidity in Heart Failure: a Multivariate Biomarker Approach
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.
Read the detailed description
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)
- Faecal and plasma metabolite content will be correlated with matrix of global muscle function to assess if there are differences according to sarcopenia status in heart failure.
- Utilizing metabolomic data to disclose dysregulation of pathways linked to energy production (Krebs cycle, Warburg effect), amino acid catabolism and free fatty acids and Bile acids. I will investigate these relationships with gut microbiome composition.
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.
- Conditions
- Heart Failure, Sarcopenia, Muscle Weakness, Body Weight, Frailty
- Being tested
- Dual X Ray Absorptiometry
- Keywords
- Sarcopenia, Grip strength, Physical function, Muscle mass, Lean mass, Fat mass, Metabolomics, Metabolites
- Medical subject headings
- Heart Failure, Sarcopenia, Muscle Weakness, Body Weight, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual X Ray AbsorptiometryDiagnostic test
Also called Near-infrared spectroscopy, Electromyography
- Dual X Ray Absorptiometry in the combination with functional tests
- Near-infrared spectroscopy in combination with hand grip strength
| Study group | Role | What they receive |
|---|---|---|
| Patients with Heart Failure | 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%. Receives: Diagnostic Test: Dual X Ray Absorptiometry | |
| Healthy Control | older people without HF. Receives: Diagnostic Test: Dual X Ray Absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Gait Speed (m/s)
Gait speed test (10-meter walking); a physical function test for which the participants' walking speed is measured.
Measured: 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.
Measured: Baseline
Secondary outcomes (11)
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).
Measured: Baseline
Hospital admission due to cardiac event
Number of hospital admissions due to cardiac event for each participant
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Physical Activity level
International Physical Activity Questionnaire (IPAQ) (physical activity levels of each participant)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Aug 2023
- Primary completion30 Apr 2025
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool Hope University, Liverpool University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217640
- Sponsor's protocol ID
- UoL001725
- Status last verified
- Apr 2025
- First submitted
- 3 Oct 2023
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Diagnosis of Secondary Sarcopenia as a Comorbidity in Heart Failure: a Multivariate Biomarker Approach
- ClinicalTrials.gov ID
- NCT06217640
- Acronym / sponsor ID
- UoL001725
- Conditions
- Heart Failure, Sarcopenia, Muscle Weakness, Body Weight, Frailty
- Keywords
- Sarcopenia, Grip strength, Physical function, Muscle mass, Lean mass, Fat mass, Metabolomics, Metabolites
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Liverpool Hope University, Liverpool University Hospitals NHS Foundation Trust
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
- Faecal and plasma metabolite content will be correlated with matrix of global muscle function to assess if there are differences according to sarcopenia status in heart failure.
- Utilizing metabolomic data to disclose dysregulation of pathways linked to energy production (Krebs cycle, Warburg effect), amino acid catabolism and free fatty acids and Bile acids. I will investigate these relationships with gut microbiome composition.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Heart Failure | – | Diagnostic Test: Dual X Ray AbsorptiometryPatient 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%. |
| Healthy Control | – | Diagnostic Test: Dual X Ray Absorptiometryolder people without HF. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- Clinically diagnosed HF regardless of ejection fraction rate (both HFrEF and HFpEF).
- Age 50 years and older.
- BMI more than 18 and less than 30 kg/m^2.
- Must be on optimal medical treatment for three months prior to inclusion.
- Do not have contraindications to providing a blood sample.
Key exclusion criteria (6 listed)
- Receiving treatment with antibiotics, probiotics, or fish oil during the last 3 months prior to inclusion.
- Major comorbidities (i.e., cancer, Alzheimer's, type 2 diabetes, chronic kidney disease).
- Treatment with immunosuppressive drugs.
- Concurrent infections, or bowel disease.
- Patients who had received cardiac resynchronization therapy during the past 6 months will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual X Ray AbsorptiometryAlso: Near-infrared spectroscopy, Electromyography* Dual X Ray Absorptiometry in the combination with functional tests * Near-infrared spectroscopy in combination with hand grip strength | Diagnostic test | Healthy Control, Patients with Heart Failure |
Primary outcome
Appendicular Lean Mass (kg)
Time frame: Baseline
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).
Gait Speed (m/s)
Time frame: Baseline
Gait speed test (10-meter walking); a physical function test for which the participants' walking speed is measured.
Handgrip Strength (kg)
Time frame: Baseline
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.
11 secondary outcomes
Metabolomics
Time frame: Baseline
Hospital admission due to cardiac event
Time frame: up to 3 years
Short-chain fatty acid count
Time frame: Baseline
Gut microbiota count
Time frame: Baseline
Dietary Intake (kcal and grams/day)
Time frame: Baseline
Quality of Life (score)
Time frame: Baseline
Physical Activity level
Time frame: Baseline
Insomnia (score)
Time frame: Baseline
Malnutrition (score)
Time frame: Baseline
Sleep Quality (score)
Time frame: Baseline
SARC-F (score)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sarcopenia, run by University of Liverpool at 1 site in United Kingdom.
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 11 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Appendicular Lean Mass (kg) (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?
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 5 Sep 2025.