Diabetes Mellitus, Type 2 Clinical Trial
— AMENDOfficial title:
A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)
Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 102 adults will be invited and allocate by chance into two groups: either a 12-week diet or health advice on how to lose weight. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | January 1, 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse 2. Clinically stable for = 3 months (no admissions to hospital) 3. Obesity (BMI =30kg/m2 if white European or =27kg/m2 if Asian, Middle Eastern or Black ethnicity) 4. Age =18 Exclusion Criteria: 1. Inability to walk/undertake 6-minute walk test 2. Inability to follow a low-energy MRP 3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease95 4. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension 5. Severe chronic obstructive pulmonary disease (FEV1< 1.0L) 6. Severe primary valvular heart disease 7. Anaemia (Hb<100g/L) 8. Severe renal disease (eGFR < 30 ml/min/1.73 m2) 9. Weight loss > 5kg in preceding 3 months. 10. Known gallstones/previous biliary colic |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Leicester, Glenfield Hospital, Groby Road | Leicester | Leicestershire |
United Kingdom | University of Manchester, Wythenshawe Hospital, Southmoor Road | Manchester | |
United Kingdom | University of Oxford, John Radcliffe Hospital, Headley Way | Oxford |
Lead Sponsor | Collaborator |
---|---|
University of Leicester | University of Manchester, University of Oxford |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Exploratory outcome: Improving skeletal and cardiac energetics | 31P magnetic resonance spectroscopy: Cardiac PCr/ATP | Baseline and 12 weeks | |
Secondary | 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 |
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