The Sarcopenia Study

December 18, 2023 updated by: University of Leicester

The Imaging Assessment of Sarcopenia Across the Heart Failure Spectrum

The goal of this cross-sectional study is to investigate the prevalence of sarcopenia in patients with Heart Failure. The main question it aims to answer is:

Whether there is a difference in the prevalence of sarcopenia across the spectrum of HFpEF (Heart failure with preserved ejection fraction) and HFrEF (heart failure with reduced ejection fraction).

This is an observational study. The participant population involves patients with heart failure with preserved ejection fraction and heart failure with reduced ejection fraction. Healthy volunteers will be recruited as controls in addition to adults with asymptomatic Type 2 Diabetes.

Participants will undergo the following:

  1. Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA)
  2. Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength)
  3. Skeletal muscle energetics assessment (31p-Spectroscopy pre/post-exercise recovery)

Researchers will compare Heart failure groups with healthy controls and adults with asymptomatic type 2 Diabetes to see if there are significant differences in the strength, mass and quality of skeletal muscle.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Heart failure is a complex condition which affects the hearts' ability to pump blood around the body properly. Due to this complexity, it often affects multiple systems in the body and can impact the quality of life. A proportion of heart failure patients also have muscle weakness, where one can feel fatigued, and weak, and may have trouble balancing and standing. To characterise muscle weakness, it is important to look at skeletal muscle mass, strength, and function. The study will focus on the prevalence of reduced muscle strength or function, using a variety of assessments within patients with heart failure. The prevalence of muscle weakness will be investigated by running assessments to look into muscle strength, a series of simple exercise tests will be run of the calf and thigh, in addition to a walking test, a balance test and a standing test to assess whole body performance. To look at the quality of skeletal muscle, a magnetic resonance imaging (MRI) and spectroscopy session will allow us to investigate the quality of the thigh muscle and the energetics in the calf. Finally, a muscle biopsy will be performed to understand differences in muscle tissue in people with different types of heart failure.

Overall, this study will provide us with unique information on skeletal muscle strength, composition and energetics within patients with heart failure, by looking at the main factors which characterise muscle weakness.

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Contact:
          • Safiyyah Suleman

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Four groups of subjects will be recruited, subjects with HFpEF, HFrEF, asymptomatic T2D and metabolically healthy non-diabetic controls. The ongoing studies will allow the co-enrolment of participants. They will be recruited to match age, sex and ethnicity as closely as possible to the HF participants.

Description

Inclusion Criteria:

Heart Failure (HF) Patients: Stage A/B HFpEF

  1. Established clinical diagnosis of HFpEF (EF>50%)
  2. Clinically stable for ≥ 3 months (no admissions to hospital)
  3. Age ≥65
  4. Willing to provide written consent for participation in the study.

HF Patients: Stage C/D HFpEF and HFrEF

  1. Established clinical diagnosis of HFpEF (EF>50%) OR HFrEF (EF<40%)
  2. Clinically stable for ≥ 3 months (no admissions to hospital)
  3. Age ≥65
  4. Willing to provide written consent for participation in the study. Healthy volunteers

1. Age >18 2. Able to provide written informed consent Asymptomatic T2D

  1. Male or female, aged ≥18 and ≤75 years.
  2. Diagnosis of stable T2D (determined by i) formal diagnosis in primary care physician case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).

Exclusion criteria:

Heart failure

  1. Absolute contraindication to MRI
  2. Inability to walk/undertake the 6-Minute Walk Test (6MWT)
  3. Neuromuscular disorders that may impact skeletal muscle assessment, such as motor neurone disease, multiple sclerosis, skeletal muscle myopathies and myositis
  4. Regular or intermittent oral corticosteroid use
  5. Untreated hyper or hypothyroidism
  6. Heart failure-related hospitalisations in the last 3 months

Healthy volunteers

  1. Previous or current signs of HF
  2. Risk factors for the development of HF, such as hypertension, diabetes Mellitus or coronary artery disease

Asymptomatic Type 2 Diabetes Mellitus (T2D)

  1. Angina pectoris or limiting dyspnoea (>NYHA II)
  2. Major atherosclerotic disease: Symptomatic CAD, history of MI, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
  3. Atrial fibrillation or flutter.
  4. Moderate to severe valvular heart disease.
  5. History of heart failure or cardiomyopathy.
  6. Type 1 diabetes mellitus (T1DM).
  7. Low fasting C-peptide levels suggestive of adult-onset T1DM.
  8. Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2).
  9. Absolute contraindications to MRI.

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
patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

Heart Failure (HF) Patients: Stage A/B HFpEF

  1. Established clinical diagnosis of HFpEF (EF>50%)
  2. Clinically stable for ≥ 3 months (no admissions to hospital)
  3. Age ≥65
  4. Willing to provide written consent for participation in the study.
patients with Heart Failure with Reduced Ejection Fraction (HFrEF)

HF Patients: Stage C/D HFpEF and HFrEF

  1. Established clinical diagnosis of HFpEF (EF>50%) OR HFrEF (EF<40%)
  2. Clinically stable for ≥ 3 months (no admissions to hospital)
  3. Age ≥65
  4. Willing to provide written consent for participation in the study.
Asymptomatic T2D
  1. Male or female, aged ≥18 and ≤75 years.
  2. Diagnosis of stable T2D (determined by i) formal diagnosis in primary care physician case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).
Healthy Volunteers
  1. Age >18
  2. Able to provide written informed consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric quadriceps skeletal muscle mass (cm^3)
Time Frame: Through study completion, an average of 3 years
A comparison of volumetric quadriceps skeletal muscle mass (cm3) using MRI between HFpEF and HFrEF patients
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HF symptoms and quality of life
Time Frame: Baseline
Minnesota Living with Heart Failure (MLWHF) questionnaire
Baseline
Frailty assessment
Time Frame: Baseline
Edmonton Frail scale
Baseline
Comparison of Body composition
Time Frame: Baseline
Bioelectrical impedance analysis (BIA) measure of Appendicular Skeletal muscle (cm^3/height) mass between patient groups
Baseline
The difference in Muscle fat fraction (percent)
Time Frame: Baseline
The difference in Muscle fat fraction (%) using MRI (DIXON sequence) of the quadriceps between patient groups
Baseline
quadriceps Skeletal muscle strength (N)
Time Frame: Baseline
The difference in quadriceps Skeletal muscle strength (N) between patient groups
Baseline
Calf plantar flexor strength (N)
Time Frame: Baseline
The difference in Calf plantar flexor strength (N) (c-station FysioMeter) between patient groups
Baseline
Handgrip strength (N)
Time Frame: Baseline
Differences in Handgrip strength (N) (Jamar Dynamometer) between patient groups
Baseline
A comparison of post-exercise recovery metabolites
Time Frame: Baseline
A comparison of post-exercise recovery metabolites: Phosphocreatine and inorganic phosphate ratios (PCr/Pi), and Adenosine Triphosphate (ATP) using 31p-Magnetic Resonance Spectroscopy between patient groups
Baseline
A comparison in distance (metres) walked during 6MWT
Time Frame: Baseline
A comparison in distance (metres) walked during Six Minute walk test (6MWT) between patient groups
Baseline
A comparison of daily physical activity
Time Frame: Baseline
A comparison of daily physical activity behaviours as measured by accelerometry between patient groups
Baseline
The Short Physical Performance Battery (SPPB) performance
Time Frame: Baseline
A comparison of lower extremity physical performance following the SPPB test between patient groups
Baseline
Sarcopenia assessment
Time Frame: Baseline
SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) questionnaire
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
quadriceps musculoskeletal Biopsy Analysis
Time Frame: Baseline
RNA sequencing following biopsy acquisition
Baseline

Collaborators and Investigators

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

Sponsor

University of Leicester

Investigators

  • Principal Investigator: Gerry McCann, BSc, MB, ChB, MRCP, MD, University of Leicester (UoL)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 6, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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