An observational study in Heart Failure, Sarcopenia and Heart Failure With Reduced Ejection Fraction, sponsored by University of Leicester. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-19.
Sponsored by University of Leicester · Observational
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:
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.
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.
1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 419 observational studies indexed under Sarcopenia.
Browse Sarcopenia studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Heart Failure (HF) Patients: Stage A/B HFpEF
HF Patients: Stage C/D HFpEF and HFrEF
Exclusion criteria:
Heart failure
Healthy volunteers
Asymptomatic Type 2 Diabetes Mellitus (T2D)
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.
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%).
1. Age \>18 2. Able to provide written informed consent
Volumetric quadriceps skeletal muscle mass (cm^3)
A comparison of volumetric quadriceps skeletal muscle mass (cm3) using MRI between HFpEF and HFrEF patients
Time frame: Through study completion, an average of 3 years
HF symptoms and quality of life
Minnesota Living with Heart Failure (MLWHF) questionnaire
Time frame: Baseline
Frailty assessment
Edmonton Frail scale
Time frame: Baseline
Comparison of Body composition
Bioelectrical impedance analysis (BIA) measure of Appendicular Skeletal muscle (cm\^3/height) mass between patient groups
Time frame: Baseline
The difference in Muscle fat fraction (percent)
The difference in Muscle fat fraction (%) using MRI (DIXON sequence) of the quadriceps between patient groups
Time frame: Baseline
quadriceps Skeletal muscle strength (N)
The difference in quadriceps Skeletal muscle strength (N) between patient groups
Time frame: Baseline
Calf plantar flexor strength (N)
The difference in Calf plantar flexor strength (N) (c-station FysioMeter) between patient groups
Time frame: Baseline
Handgrip strength (N)
Differences in Handgrip strength (N) (Jamar Dynamometer) between patient groups
Time frame: Baseline
A comparison of post-exercise recovery metabolites
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
Time frame: Baseline
A comparison in distance (metres) walked during 6MWT
A comparison in distance (metres) walked during Six Minute walk test (6MWT) between patient groups
Time frame: Baseline
A comparison of daily physical activity
A comparison of daily physical activity behaviours as measured by accelerometry between patient groups
Time frame: Baseline
The Short Physical Performance Battery (SPPB) performance
A comparison of lower extremity physical performance following the SPPB test between patient groups
Time frame: Baseline
Sarcopenia assessment
SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) questionnaire
Time frame: Baseline
quadriceps musculoskeletal Biopsy Analysis
RNA sequencing following biopsy acquisition
Time frame: Baseline
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