Study Results
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Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2023-12-06
2026-09-01
Brief Summary
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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.
Detailed Description
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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
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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%).
No interventions assigned to this group
Healthy Volunteers
1. Age \>18
2. Able to provide written informed consent
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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University of Leicester
OTHER
Responsible Party
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Principal Investigators
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Gerry McCann, BSc, MB, ChB, MRCP, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leicester (UoL)
Locations
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University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Safiyyah Suleman
Role: primary
References
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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.
Murphy 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.
Del 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.
Pandey 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.
Salmon 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.
Cruz-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.
Tucker 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.
Uchmanowicz 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.
Kitzman 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.
Kirkman 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.
Bilak 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.
Kinugasa 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.
Pandey 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.
Hamada 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.
Visser 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.
Oba H, Matsui Y, Arai H, Watanabe T, Iida H, Mizuno T, Yamashita S, Ishizuka S, Suzuki Y, Hiraiwa H, Imagama S. Evaluation of muscle quality and quantity for the assessment of sarcopenia using mid-thigh computed tomography: a cohort study. BMC Geriatr. 2021 Apr 13;21(1):239. doi: 10.1186/s12877-021-02187-w.
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Weiss K, Schar M, Panjrath GS, Zhang Y, Sharma K, Bottomley PA, Golozar A, Steinberg A, Gerstenblith G, Russell SD, Weiss RG. Fatigability, Exercise Intolerance, and Abnormal Skeletal Muscle Energetics in Heart Failure. Circ Heart Fail. 2017 Jul;10(7):e004129. doi: 10.1161/CIRCHEARTFAILURE.117.004129.
Kitzman DW, Brubaker P, Morgan T, Haykowsky M, Hundley G, Kraus WE, Eggebeen J, Nicklas BJ. Effect of Caloric Restriction or Aerobic Exercise Training on Peak Oxygen Consumption and Quality of Life in Obese Older Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2016 Jan 5;315(1):36-46. doi: 10.1001/jama.2015.17346.
Molina AJ, Bharadwaj MS, Van Horn C, Nicklas BJ, Lyles MF, Eggebeen J, Haykowsky MJ, Brubaker PH, Kitzman DW. Skeletal Muscle Mitochondrial Content, Oxidative Capacity, and Mfn2 Expression Are Reduced in Older Patients With Heart Failure and Preserved Ejection Fraction and Are Related to Exercise Intolerance. JACC Heart Fail. 2016 Aug;4(8):636-45. doi: 10.1016/j.jchf.2016.03.011. Epub 2016 May 11.
O'Neill S, Weeks A, Norgaard JE, Jorgensen MG. Validity and intrarater reliability of a novel device for assessing Plantar flexor strength. PLoS One. 2023 Mar 31;18(3):e0282395. doi: 10.1371/journal.pone.0282395. eCollection 2023.
Brubaker PH, Nicklas BJ, Houston DK, Hundley WG, Chen H, Molina AJA, Lyles WM, Nelson B, Upadhya B, Newland R, Kitzman DW. A Randomized, Controlled Trial of Resistance Training Added to Caloric Restriction Plus Aerobic Exercise Training in Obese Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2023 Feb;16(2):e010161. doi: 10.1161/CIRCHEARTFAILURE.122.010161. Epub 2022 Oct 31.
Konishi M, Kagiyama N, Kamiya K, Saito H, Saito K, Ogasahara Y, Maekawa E, Misumi T, Kitai T, Iwata K, Jujo K, Wada H, Kasai T, Nagamatsu H, Ozawa T, Izawa K, Yamamoto S, Aizawa N, Makino A, Oka K, Momomura SI, Matsue Y. Impact of sarcopenia on prognosis in patients with heart failure with reduced and preserved ejection fraction. Eur J Prev Cardiol. 2021 Aug 9;28(9):1022-1029. doi: 10.1093/eurjpc/zwaa117.
Sugita Y, Ito K, Yoshioka Y, Sakai S. Association of complication of type 2 diabetes mellitus with hemodynamics and exercise capacity in patients with heart failure with preserved ejection fraction: a case-control study in individuals aged 65-80 years. Cardiovasc Diabetol. 2023 Apr 28;22(1):97. doi: 10.1186/s12933-023-01835-2.
Other Identifiers
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0916
Identifier Type: -
Identifier Source: org_study_id