Multivariate Biomarker Study for Sarcopenia in Heart Failure

NCT06217640 | Active Not Recruiting DMC

• 1 other identifier: UoL001725
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Failure; Sarcopenia; Muscle Weakness; Body Weight; Frailty

Keywords

Sarcopenia; Grip strength; Physical function; Muscle mass; Lean mass; Fat mass; Metabolomics; Metabolites

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline

• Gait Speed (m/s)

  Gait speed test (10-meter walking); a physical function test for which the participants' walking speed is 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.

  Baseline

Secondary Outcomes (11)

• Metabolomics

  Baseline

• Hospital admission due to cardiac event

  up to 3 years

• Short-chain fatty acid count

  Baseline

• Gut microbiota count

  Baseline

• Dietary Intake (kcal and grams/day)

  Baseline

Study Arms (2)

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

Healthy Control

older people without HF.

Diagnostic Test: Dual X Ray Absorptiometry

Interventions

Dual X Ray Absorptiometry DIAGNOSTIC_TEST

* 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

Healthy Control; Patients with Heart Failure

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: both men and women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Do not have contraindications to providing a blood sample.
• Sufficient mental capacity to consent as determined by the researchers.
• Able to walk with or without a walker for at least 16 m.
• No objection to the researchers contacting their general practitioner and neurologist.

You may not qualify if:

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

Sponsors & Collaborators

• University of Liverpool: lead
• Liverpool Hope University: collaborator
• Liverpool University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L97AL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

MeSH Terms

Conditions

Heart Failure; Sarcopenia; Muscle Weakness; Body Weight; Frailty

Interventions

Absorptiometry, Photon; Spectroscopy, Near-Infrared; Electromyography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Spectrum Analysis; Electrodiagnosis; Myography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: January 22, 2024
• Study Start: August 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-04

Locations

GB (1)