An observational study in Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes, 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 2026-04-30.
Sponsored by University of Leicester · Observational
Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart cannot fill with blood effectively. As a result, people with HFpEF suffer fatigue, breathlessness, and develop swollen limbs. The condition often requires multiple admissions to hospital and is associated with a marked loss of lifespan.
Despite being so common, very little is known about why people develop HFpEF and there are hardly any known treatments. Type 2 diabetes (T2D) is a major risk factor for HFpEF, and people with both HFpEF and diabetes are at a heightened risk of hospitalisation and premature death. It is unclear why the combination of diabetes and HFpEF is particularly harmful. This may be related to the hearts of people with type 2 diabetes being unable to take up the mineral calcium properly, as well as due to their hearts being less energy efficient. Both of these are vital to heart muscle pumping and filling, but until recently it has not been possible to assess these in humans.
New advances in heart MRI scans, with dedicated scanner techniques and dyes (manganese contrast), now allow extremely detailed pictures of heart structure, function, calcium uptake and energy efficiency, all during the same scan. The investigators will enlist 40 volunteers with HFpEF (20 with T2D and 20 without T2D), and up to 20 healthy volunteers, to undergo a heart MRI scan with manganese contrast to assess calcium uptake and energy efficiency. This will allow the comparison of people with HFpEF with and without T2D, to see how their hearts are different to healthy volunteers.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 60 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 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.
Primary and secondary care patients
Exclusion Criteria:
Participants with heart failure with preserved ejection fraction and type 2 diabetes
Other: Minnesota Living with Heart Failure Questionnaire · Diagnostic Test: Echocardiogram · Diagnostic Test: Six-minute walk test · Diagnostic Test: Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy · Diagnostic Test: Cardiovascular magnetic resonance scan · Diagnostic Test: Blood tests
Participants with heart failure with preserved ejection fraction but without type 2 diabetes
Other: Minnesota Living with Heart Failure Questionnaire · Diagnostic Test: Echocardiogram · Diagnostic Test: Six-minute walk test · Diagnostic Test: Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy · Diagnostic Test: Cardiovascular magnetic resonance scan · Diagnostic Test: Blood tests
Healthy volunteers without heart failure or type 2 diabetes
Other: Minnesota Living with Heart Failure Questionnaire · Diagnostic Test: Echocardiogram · Diagnostic Test: Six-minute walk test · Diagnostic Test: Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy · Diagnostic Test: Cardiovascular magnetic resonance scan · Diagnostic Test: Blood tests
Self-administered, validated questionnaire to assess symptoms of heart failure
Resting transthoracic echocardiogram to exclude valvular pathology and the assess indices of systolic and diastolic function and speckle tracking for strain
Standardised, objective assessment of exercise capacity
Using a 3-Tesla scanner, 31P magnetic resonance spectroscopy will be performed to obtain information regarding cardiac energetics. An intravenous infusion of manganese dipyridoxyl diphosphate (mangafodipir, MnDPDP) will be commenced at a rate of 1mL/min using a dose of 5µmol/kg (0.1mL/kg).
Scan including adenosine stress perfusion
Full blood count, Urea and electrolytes, Liver function tests, Glucose and HbA1c, Insulin and C-peptide, NTproBNP, High sensitive troponin I, storage of plasma for future analyses
Ki
Manganese influx constant as measured by MEMRI scan
Time frame: Baseline
T1 values
T1 values measured at 30 minutes post contrast on MEMRI scan
Time frame: Baseline
Myocardial PCr/ATP ratio
Phosphocreatine-to-ATP ratio as measured by 31P-magnetic resonance spectroscopy
Time frame: Baseline
Left ventricular ejection fraction
%, measured by CMR
Time frame: Baseline
LV global longitudinal strain
%, measured by CMR
Time frame: Baseline
LV global circumferential strain
%, measured by CMR
Time frame: Baseline
LV PEDSR
1/s, measured by CMR
Time frame: Baseline
LV mass
grams, measured by CMR
Time frame: Baseline
LV mass/volume ratio
Measured by CMR
Time frame: Baseline
Myocardial fibrosis
CMR assessed markers of LV myocardial fibrosis (extracellular volume)
Time frame: Baseline
Myocardial Perfusion
CMR assessed markers of perfusion (myocardial perfusion reserve)
Time frame: Baseline
Associations of Ki with resting PCr/ATP
Univariate and multivariate models to look for association between Ki and PCr/ATP ratio
Time frame: Baseline
Associations of exercise capacity with Ki and PCr/ATP in HFpEF
Ki values as assessed by MEMRI, myocardial PCr/ATP as measured by 31P-MRS and six minute walk test distance. Associations will be assessed using univariate and multivariate models.
Time frame: Baseline
Plasma biomarkers of metabolic dysregulation, fibrosis and inflammation
This exploratory outcome will assess the differences in a wide range of plasma biomarkers between groups and their association with Ki
Time frame: Baseline
10-year outcomes
10-year outcomes including HF hospitalisation (time to first event and cumulative) and all-cause death.
Time frame: Baseline
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University of Leicester