RecruitingNCT06652763

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


Sponsor

University of Leicester

Enrollment

60 participants

Start Date

Oct 10, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of MRI called manganese-enhanced MRI (MEMRI) to better understand and diagnose heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but is too stiff. The scan uses a small amount of manganese (a mineral) as a contrast agent to highlight heart muscle activity. **You may be eligible if...** - You have symptoms or a confirmed diagnosis of heart failure with a normal pumping function (ejection fraction of 50% or higher) - You meet established diagnostic criteria for HFpEF - You are able to give informed consent **You may NOT be eligible if...** - You have heart failure with reduced pumping function (ejection fraction below 50%) - You have kidney problems that make the MRI contrast agent unsafe - You cannot undergo an MRI scan (e.g., certain metal implants) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMinnesota Living with Heart Failure Questionnaire

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

DIAGNOSTIC_TESTEchocardiogram

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

DIAGNOSTIC_TESTSix-minute walk test

Standardised, objective assessment of exercise capacity

DIAGNOSTIC_TESTManganese-enhanced MRI and 31-P magnetic resonance spectroscopy

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).

DIAGNOSTIC_TESTCardiovascular magnetic resonance scan

Scan including adenosine stress perfusion

DIAGNOSTIC_TESTBlood tests

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


Locations(1)

University of Leicester

Leicester, United Kingdom

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NCT06652763


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