| Trial ID: | L6728 |
| Source ID: | NCT05887271
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| Associated Drug: |
Low Calorie Meal Replacement Plan
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| Title: |
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
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| Acronym: |
AMEND
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Heart Failure With Preserved Ejection Fraction|Heart Failure, Diastolic|Diabetes Mellitus, Type 2|Diabetes Mellitus Type 2 in Obese|Obesity Adult Onset
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| Interventions: |
DRUG: Low calorie meal replacement plan|DIAGNOSTIC_TEST: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy|DIAGNOSTIC_TEST: Transthoracic echocardiography|DIAGNOSTIC_TEST: Blood test|DIAGNOSTIC_TEST: Electrocardiogram|DIAGNOSTIC_TEST: Accelerometery|DIAGNOSTIC_TEST: 6 minute walk test (6MWT)|DIAGNOSTIC_TEST: Skeletal muscle strength using handgrip strength and quadriceps (Cybex dynamometer)|OTHER: Assessment of quality of life and heart failure symptoms|OTHER: Assessment of sarcopenia|OTHER: Assessment of frailty|OTHER: Qualitative interview|DIAGNOSTIC_TEST: Skeletal muscle magnetic resonance spectroscopy
|
| Outcome Measures: |
Primary: Change in the distance walked during 6 minute walk test (6MWT), The primary outcome measure is a change in the distance walked on 6MWT measured in meters, Assessed at baseline and 12 weeks, optional repeat at 24 weeks | Secondary: Beneficial reverse cardiovascular remodelling, CMR-derived measures of cardiovascular remodelling defined as left ventricular mass/volume ratio, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Change in physical activity levels, Improvement in physical activity will be determined by change in daily activity as determined accelerometery, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Change in lower limb muscle power, Change in muscle power will be determined by quadriceps strength measured using Cybex dynanometer, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Change in upper limb muscle power, Change in muscle power will be determined by handgrip strength using fysiometer, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Improvement in exercise tolerance, This will be assessed by a)change in Borg dyspnoea scale during 6MWT, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Improvement in symptoms of heart failure, This will be assessed by a change in the Minessota Living with Heart failure score, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Change in frailty, This will be assessed by a change in the Edmonton frailty questionnaire score, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Change in sarcopenia, This will be assessed by a change in the SARC-F questionnaire score, Assessed at baseline and 12 weeks, optional repeat at 24 weeks|Exploratory outcome: Improving skeletal and cardiac energetics, 31P magnetic resonance spectroscopy: Cardiac PCr/ATP, Baseline and 12 weeks|Exploratory outcome: change in fibroinflammatory biomarker panel, Exploratory analysis of the O-link fibroinflammatory biomarker panel to identify potential pathways involved in the development, progression or outcomes of HFpEF., This will be evaluated at baseline and at 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Leicester | Collaborators: University of Oxford|University of Manchester
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2023-12-05
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| Completion Date: |
2026-01-01
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| Results First Posted: |
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| Last Update Posted: |
2024-10-30
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| Locations: |
University of Leicester, Glenfield Hospital, Groby Road, Leicester, Leicestershire, LE3 9QP, United Kingdom|University of Manchester, Wythenshawe Hospital, Southmoor Road, Manchester, M23 9LT, United Kingdom|University of Oxford, John Radcliffe Hospital, Headley Way, Oxford, OX3 9DU, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT05887271
|
