Health TrialsbyHealthPanel

Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction

ConditionsHeart Failure With Preserved Ejection FractionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Capacity to provide informed consent

Symptoms (e.g. breathlessness, orthopnoea, ankle swelling, fatigue), signs (e.g. elevated jugular venous pressure, peripheral oedema, third heart sound) or established diagnosis of HF with LV ejection fraction ≥ 50%, or

Meets HFpEF diagnostic criteria in accordance with the HFA-PEFF diagnostic algorithm form the Heart Failure Association of the European Society of Cardiology, in which a score ≥5 points confirms diagnosis of HFpEF

Disqualifiers

Known diagnosis of Type 1 Diabetes

Pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test

Receiving an investigational drug or device within 30 days prior to participating in the study

Decompensated heart failure or pulmonary oedema

Trial population

Primary and secondary care patients

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Minnesota Living with Heart Failure Questionnaire

    Other intervention

    Self-administered, validated questionnaire to assess symptoms of heart failure

  • Echocardiogram

    Diagnostic test

    Resting transthoracic echocardiogram to exclude valvular pathology and the assess indices of systolic and diastolic function and speckle tracking for strain

  • Six-minute walk test

    Diagnostic test

    Standardised, objective assessment of exercise capacity

  • Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy

    Diagnostic test

    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).

  • Cardiovascular magnetic resonance scan

    Diagnostic test

    Scan including adenosine stress perfusion

  • Blood tests

    Diagnostic test

    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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: HFpEF with T2D6 interventions
Group B: HFpEF without T2D6 interventions
Group C: Controls6 interventions

Trial outcomes

Primary outcomes

1

Ki

Manganese influx constant as measured by MEMRI scan

Time frame
Baseline

Secondary outcomes

1

T1 values

T1 values measured at 30 minutes post contrast on MEMRI scan

Time frame
Baseline
2

Myocardial PCr/ATP ratio

Phosphocreatine-to-ATP ratio as measured by 31P-magnetic resonance spectroscopy

Time frame
Baseline
3

Left ventricular ejection fraction

%, measured by CMR

Time frame
Baseline
4

LV global longitudinal strain

%, measured by CMR

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leicester

Lead sponsor

Source ClinicalTrials.gov
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