Multivariate Biomarker Study for Sarcopenia in Heart Failure

August 28, 2025 updated by: University of Liverpool

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L97AL
        • Liverpool University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion criteria for HF:

  1. Clinically diagnosed HF regardless of ejection fraction rate (both HFrEF and HFpEF).
  2. Age 50 years and older.
  3. BMI more than 18 and less than 30 kg/m^2.
  4. Must be on optimal medical treatment for three months prior to inclusion.
  5. Do not have contraindications to providing a blood sample.
  6. Sufficient mental capacity to consent as determined by the researchers.
  7. Able to walk with or without a walker for at least 16 m.
  8. No objection to the researchers contacting their general practitioner and neurologist.

Exclusion criteria for HF:

  1. Receiving treatment with antibiotics, probiotics, or fish oil during the last 3 months prior to inclusion.
  2. Major comorbidities (i.e., cancer, Alzheimer's, type 2 diabetes, chronic kidney disease).
  3. Treatment with immunosuppressive drugs.
  4. Concurrent infections, or bowel disease.
  5. Patients who had received cardiac resynchronization therapy during the past 6 months will not be included.
  6. Participants must also not be on any other clinical trial during the study.

Inclusion criteria for Healthy controls:

  1. No history of chronic disease and will be screened for hypertension.
  2. BMI more than 18 and less than 30 kg/m^2.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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%.
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
Other Names:
  • Near-infrared spectroscopy
  • Electromyography
Healthy Control
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
Other Names:
  • Near-infrared spectroscopy
  • Electromyography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Baseline
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolomics
Time Frame: Baseline
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).
Baseline
Hospital admission due to cardiac event
Time Frame: up to 3 years
Number of hospital admissions due to cardiac event for each participant
up to 3 years
Short-chain fatty acid count
Time Frame: Baseline
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.
Baseline
Gut microbiota count
Time Frame: Baseline
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.
Baseline
Dietary Intake (kcal and grams/day)
Time Frame: Baseline
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.
Baseline
Quality of Life (score)
Time Frame: Baseline

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.
Baseline
Physical Activity level
Time Frame: Baseline
International Physical Activity Questionnaire (IPAQ) (physical activity levels of each participant)
Baseline
Insomnia (score)
Time Frame: Baseline

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).
Baseline
Malnutrition (score)
Time Frame: Baseline
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.
Baseline
Sleep Quality (score)
Time Frame: Baseline

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.
Baseline
SARC-F (score)
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liverpool

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Liverpool University Hospitals NHS Foundation Trust
Liverpool Hope University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UoL001725

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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