Heart FailureNCT05888688
The Sarcopenia Study
An observational study of Heart Failure and Sarcopenia, run by University of Leicester at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Sarcopenia, Heart Failure With Reduced Ejection Fraction
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2023to 1 Sep 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Heart Failure (HF) Patients: Stage A/B HFpEF
- Established clinical diagnosis of HFpEF (EF>50%)
- Clinically stable for ≥ 3 months (no admissions to hospital)
- Age ≥65
- Willing to provide written consent for participation in the study.
- HF Patients: Stage C/D HFpEF and HFrEF
Show all 13Show fewer
- Established clinical diagnosis of HFpEF (EF>50%) OR HFrEF (EF<40%)
- Clinically stable for ≥ 3 months (no admissions to hospital)
- Age ≥65
- Willing to provide written consent for participation in the study. Healthy volunteers
- 1. Age >18 2. Able to provide written informed consent Asymptomatic T2D
- Male or female, aged ≥18 and ≤75 years.
- 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%).
Who cannot join
- Heart failure
- Absolute contraindication to MRI
- Inability to walk/undertake the 6-Minute Walk Test (6MWT)
- Neuromuscular disorders that may impact skeletal muscle assessment, such as motor neurone disease, multiple sclerosis, skeletal muscle myopathies and myositis
- Regular or intermittent oral corticosteroid use
- Untreated hyper or hypothyroidism
Show all 20Show fewer
- Heart failure-related hospitalisations in the last 3 months
- Healthy volunteers
- Previous or current signs of HF
- Risk factors for the development of HF, such as hypertension, diabetes Mellitus or coronary artery disease
- Asymptomatic Type 2 Diabetes Mellitus (T2D)
- Angina pectoris or limiting dyspnoea (>NYHA II)
- Major atherosclerotic disease: Symptomatic CAD, history of MI, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
- Atrial fibrillation or flutter.
- Moderate to severe valvular heart disease.
- History of heart failure or cardiomyopathy.
- Type 1 diabetes mellitus (T1DM).
- Low fasting C-peptide levels suggestive of adult-onset T1DM.
- Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2).
- Absolute contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Safiyyah Suleman
About this study
Official title: 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).
Read more
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:
- Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA)
- Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength)
- 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.
Read the 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.
- Conditions
- Heart Failure, Sarcopenia, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes, Frailty
- Keywords
- Heart Failure, Sarcopenia, Frailty, Skeletal Muscle, Magnetic Resonance Imaging, 31-Phosphorous magnetic resonance spectroscopy
- Medical subject headings
- Heart Failure, Sarcopenia, Diabetes Mellitus, Type 2, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Volumetric quadriceps skeletal muscle mass (cm^3)
A comparison of volumetric quadriceps skeletal muscle mass (cm3) using MRI between HFpEF and HFrEF patients
Measured: Through study completion, an average of 3 years
Secondary outcomes (12)
HF symptoms and quality of life
Minnesota Living with Heart Failure (MLWHF) questionnaire
Measured: Baseline
Frailty assessment
Edmonton Frail scale
Measured: Baseline
Comparison of Body composition
Bioelectrical impedance analysis (BIA) measure of Appendicular Skeletal muscle (cm^3/height) mass between patient groups
Measured: Baseline
The difference in Muscle fat fraction (percent)
The difference in Muscle fat fraction (%) using MRI (DIXON sequence) of the quadriceps between patient groups
Measured: Baseline
quadriceps Skeletal muscle strength (N)
The difference in quadriceps Skeletal muscle strength (N) between patient groups
Measured: Baseline
Calf plantar flexor strength (N)
The difference in Calf plantar flexor strength (N) (c-station FysioMeter) between patient groups
Measured: Baseline
Handgrip strength (N)
Differences in Handgrip strength (N) (Jamar Dynamometer) between patient groups
Measured: 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
Measured: Baseline
A comparison in distance (metres) walked during 6MWT
A comparison in distance (metres) walked during Six Minute walk test (6MWT) between patient groups
Measured: Baseline
A comparison of daily physical activity
A comparison of daily physical activity behaviours as measured by accelerometry between patient groups
Measured: Baseline
The Short Physical Performance Battery (SPPB) performance
A comparison of lower extremity physical performance following the SPPB test between patient groups
Measured: Baseline
Sarcopenia assessment
SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start6 Dec 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- 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)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerry McCann, BSc, MB, ChB, MRCP, MD, Principal investigator, University of Leicester (UoL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888688
- Sponsor's protocol ID
- 0916
- Status last verified
- Dec 2023
- First submitted
- 15 May 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Redfield MM, Borlaug BA. Heart Failure With Preserved Ejection Fraction: A Review. JAMA. 2023 Mar 14;329(10):827-838. doi: 10.1001/jama.2023.2020.
PubMed 36917048Murphy SP, Ibrahim NE, Januzzi JL Jr. Heart Failure With Reduced Ejection Fraction: A Review. JAMA. 2020 Aug 4;324(5):488-504. doi: 10.1001/jama.2020.10262.
PubMed 32749493Del Buono MG, Arena R, Borlaug BA, Carbone S, Canada JM, Kirkman DL, Garten R, Rodriguez-Miguelez P, Guazzi M, Lavie CJ, Abbate A. Exercise Intolerance in Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 May 7;73(17):2209-2225. doi: 10.1016/j.jacc.2019.01.072.
PubMed 31047010Pandey A, Shah SJ, Butler J, Kellogg DL Jr, Lewis GD, Forman DE, Mentz RJ, Borlaug BA, Simon MA, Chirinos JA, Fielding RA, Volpi E, Molina AJA, Haykowsky MJ, Sam F, Goodpaster BH, Bertoni AG, Justice JN, White JP, Ding J, Hummel SL, LeBrasseur NK, Taffet GE, Pipinos II, Kitzman D. Exercise Intolerance in Older Adults With Heart Failure With Preserved Ejection Fraction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Sep 14;78(11):1166-1187. doi: 10.1016/j.jacc.2021.07.014.
PubMed 34503685Salmon T, Essa H, Tajik B, Isanejad M, Akpan A, Sankaranarayanan R. The Impact of Frailty and Comorbidities on Heart Failure Outcomes. Card Fail Rev. 2022 Mar 21;8:e07. doi: 10.15420/cfr.2021.29. eCollection 2022 Jan.
PubMed 35399550Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Tucker WJ, Haykowsky MJ, Seo Y, Stehling E, Forman DE. Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. Curr Heart Fail Rep. 2018 Dec;15(6):323-331. doi: 10.1007/s11897-018-0408-6.
PubMed 30178183Uchmanowicz I, Mlynarska A, Lisiak M, Kaluzna-Oleksy M, Wleklik M, Chudiak A, Dudek M, Migaj J, Hinterbuchner L, Gobbens R. Heart Failure and Problems with Frailty Syndrome: Why it is Time to Care About Frailty Syndrome in Heart Failure. Card Fail Rev. 2019 Feb;5(1):37-43. doi: 10.15420/cfr.2018.37.1.
PubMed 30847244Kitzman DW, Nicklas B, Kraus WE, Lyles MF, Eggebeen J, Morgan TM, Haykowsky M. Skeletal muscle abnormalities and exercise intolerance in older patients with heart failure and preserved ejection fraction. Am J Physiol Heart Circ Physiol. 2014 May;306(9):H1364-70. doi: 10.1152/ajpheart.00004.2014. Epub 2014 Mar 21.
PubMed 24658015Kirkman DL, Bohmke N, Billingsley HE, Carbone S. Sarcopenic Obesity in Heart Failure With Preserved Ejection Fraction. Front Endocrinol (Lausanne). 2020 Sep 30;11:558271. doi: 10.3389/fendo.2020.558271. eCollection 2020.
PubMed 33117276Bilak JM, Gulsin GS, McCann GP. Cardiovascular and systemic determinants of exercise capacity in people with type 2 diabetes mellitus. Ther Adv Endocrinol Metab. 2021 Jan 27;12:2042018820980235. doi: 10.1177/2042018820980235. eCollection 2021.
PubMed 33552463Kinugasa Y, Yamamoto K. The challenge of frailty and sarcopenia in heart failure with preserved ejection fraction. Heart. 2017 Feb;103(3):184-189. doi: 10.1136/heartjnl-2016-309995. Epub 2016 Dec 9.
PubMed 27940967Pandey A, Parashar A, Kumbhani D, Agarwal S, Garg J, Kitzman D, Levine B, Drazner M, Berry J. Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials. Circ Heart Fail. 2015 Jan;8(1):33-40. doi: 10.1161/CIRCHEARTFAILURE.114.001615. Epub 2014 Nov 16.
PubMed 25399909Hamada T, Kubo T, Kawai K, Nakaoka Y, Yabe T, Furuno T, Yamada E, Kitaoka H; Kochi YOSACOI study. Clinical characteristics and frailty status in heart failure with preserved vs. reduced ejection fraction. ESC Heart Fail. 2022 Jun;9(3):1853-1863. doi: 10.1002/ehf2.13885. Epub 2022 Mar 30.
PubMed 35355441Visser M, Goodpaster BH, Kritchevsky SB, Newman AB, Nevitt M, Rubin SM, Simonsick EM, Harris TB. Muscle mass, muscle strength, and muscle fat infiltration as predictors of incident mobility limitations in well-functioning older persons. J Gerontol A Biol Sci Med Sci. 2005 Mar;60(3):324-33. doi: 10.1093/gerona/60.3.324.
PubMed 15860469
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Imaging Assessment of Sarcopenia Across the Heart Failure Spectrum
- ClinicalTrials.gov ID
- NCT05888688
- Acronym / sponsor ID
- 0916
- Conditions
- Heart Failure, Sarcopenia, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes, Frailty
- Keywords
- Heart Failure, Sarcopenia, Frailty, Skeletal Muscle, Magnetic Resonance Imaging, 31-Phosphorous magnetic resonance spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Jun 2023 (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.
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:
- Skeletal muscle mass, quality and body composition assessments using magnetic resonance imaging (MRI) and bioelectrical impedance analysis (BIA)
- Skeletal muscle strength assessments (Dynamometer, FysioMeter, handgrip strength)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Heart Failure (HF) Patients: Stage A/B HFpEF
- Established clinical diagnosis of HFpEF (EF>50%)
- Clinically stable for ≥ 3 months (no admissions to hospital)
- Age ≥65
- Willing to provide written consent for participation in the study.
Key exclusion criteria (20 listed)
- Heart failure
- Absolute contraindication to MRI
- Inability to walk/undertake the 6-Minute Walk Test (6MWT)
- Neuromuscular disorders that may impact skeletal muscle assessment, such as motor neurone disease, multiple sclerosis, skeletal muscle myopathies and myositis
- Regular or intermittent oral corticosteroid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
HF symptoms and quality of life
Time frame: Baseline
Frailty assessment
Time frame: Baseline
Comparison of Body composition
Time frame: Baseline
The difference in Muscle fat fraction (percent)
Time frame: Baseline
quadriceps Skeletal muscle strength (N)
Time frame: Baseline
Calf plantar flexor strength (N)
Time frame: Baseline
Handgrip strength (N)
Time frame: Baseline
A comparison of post-exercise recovery metabolites
Time frame: Baseline
A comparison in distance (metres) walked during 6MWT
Time frame: Baseline
A comparison of daily physical activity
Time frame: Baseline
The Short Physical Performance Battery (SPPB) performance
Time frame: Baseline
Sarcopenia assessment
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Background: PubMed 36917048Redfield MM, Borlaug BA. Heart Failure With Preserved Ejection Fraction: A Review. JAMA. 2023 Mar 14;329(10):827-838. doi: 10.1001/jama.2023.2020.
- Background: PubMed 32749493Murphy SP, Ibrahim NE, Januzzi JL Jr. Heart Failure With Reduced Ejection Fraction: A Review. JAMA. 2020 Aug 4;324(5):488-504. doi: 10.1001/jama.2020.10262.
- Background: PubMed 31047010Del Buono MG, Arena R, Borlaug BA, Carbone S, Canada JM, Kirkman DL, Garten R, Rodriguez-Miguelez P, Guazzi M, Lavie CJ, Abbate A. Exercise Intolerance in Patients With Heart Failure: JACC State-of-the-Art Review. J Am Coll Cardiol. 2019 May 7;73(17):2209-2225. doi: 10.1016/j.jacc.2019.01.072.
- Background: PubMed 34503685Pandey A, Shah SJ, Butler J, Kellogg DL Jr, Lewis GD, Forman DE, Mentz RJ, Borlaug BA, Simon MA, Chirinos JA, Fielding RA, Volpi E, Molina AJA, Haykowsky MJ, Sam F, Goodpaster BH, Bertoni AG, Justice JN, White JP, Ding J, Hummel SL, LeBrasseur NK, Taffet GE, Pipinos II, Kitzman D. Exercise Intolerance in Older Adults With Heart Failure With Preserved Ejection Fraction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2021 Sep 14;78(11):1166-1187. doi: 10.1016/j.jacc.2021.07.014.
- Background: PubMed 35399550Salmon T, Essa H, Tajik B, Isanejad M, Akpan A, Sankaranarayanan R. The Impact of Frailty and Comorbidities on Heart Failure Outcomes. Card Fail Rev. 2022 Mar 21;8:e07. doi: 10.15420/cfr.2021.29. eCollection 2022 Jan.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 30178183Tucker WJ, Haykowsky MJ, Seo Y, Stehling E, Forman DE. Impaired Exercise Tolerance in Heart Failure: Role of Skeletal Muscle Morphology and Function. Curr Heart Fail Rep. 2018 Dec;15(6):323-331. doi: 10.1007/s11897-018-0408-6.
- Results publication: PubMed 30847244Uchmanowicz I, Mlynarska A, Lisiak M, Kaluzna-Oleksy M, Wleklik M, Chudiak A, Dudek M, Migaj J, Hinterbuchner L, Gobbens R. Heart Failure and Problems with Frailty Syndrome: Why it is Time to Care About Frailty Syndrome in Heart Failure. Card Fail Rev. 2019 Feb;5(1):37-43. doi: 10.15420/cfr.2018.37.1.
- Results publication: PubMed 24658015Kitzman DW, Nicklas B, Kraus WE, Lyles MF, Eggebeen J, Morgan TM, Haykowsky M. Skeletal muscle abnormalities and exercise intolerance in older patients with heart failure and preserved ejection fraction. Am J Physiol Heart Circ Physiol. 2014 May;306(9):H1364-70. doi: 10.1152/ajpheart.00004.2014. Epub 2014 Mar 21.
- Results publication: PubMed 33117276Kirkman DL, Bohmke N, Billingsley HE, Carbone S. Sarcopenic Obesity in Heart Failure With Preserved Ejection Fraction. Front Endocrinol (Lausanne). 2020 Sep 30;11:558271. doi: 10.3389/fendo.2020.558271. eCollection 2020.
- Results publication: PubMed 33552463Bilak JM, Gulsin GS, McCann GP. Cardiovascular and systemic determinants of exercise capacity in people with type 2 diabetes mellitus. Ther Adv Endocrinol Metab. 2021 Jan 27;12:2042018820980235. doi: 10.1177/2042018820980235. eCollection 2021.
- Results publication: PubMed 27940967Kinugasa Y, Yamamoto K. The challenge of frailty and sarcopenia in heart failure with preserved ejection fraction. Heart. 2017 Feb;103(3):184-189. doi: 10.1136/heartjnl-2016-309995. Epub 2016 Dec 9.
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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.
Gerry McCann, BSc, MB, ChB, MRCP, MD principal investigator
University of Leicester (UoL)
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 Leicester 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 13 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 19 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sally Utton (44 (0)116 204 4786, su47@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric quadriceps skeletal muscle mass (cm^3) (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888688, which also lists 24 linked publications.
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 19 Dec 2023.