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

Last updated: December 2, 2024
Sponsor: University of Leicester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Congestive Heart Failure

Diabetes Mellitus Types I And Ii

Treatment

Six-minute walk test

Cardiovascular magnetic resonance scan

Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy

Clinical Study ID

NCT06652763
0883
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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) orestablished diagnosis of HF with LV ejection fraction ≥ 50%, or

  • Meets HFpEF diagnostic criteria in accordance with the HFA-PEFF diagnostic algorithmform the Heart Failure Association of the European Society of Cardiology, in which ascore ≥5 points confirms diagnosis of HFpEF

Exclusion

Exclusion Criteria:

  • Known diagnosis of Type 1 Diabetes

  • Pregnancy or breast-feeding or females of child bearing age without a negativepregnancy test

  • Receiving an investigational drug or device within 30 days prior to participating inthe study

  • Decompensated heart failure or pulmonary oedema

  • History of prolonged corrected QT interval or torsades de pointes

  • Second- or third-degree atrioventricular block

  • Abnormal liver function tests (> 3x upper limit of normal) or history of liverdisease

  • Baseline eGFR < 30mL/min/1.73m2

  • Any contraindications to MRI including implanted devices/pacemakers

  • Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditisor hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.

  • Recent myocardial infarction within the previous 3 months

  • Known diagnosis of pheochromocytoma

Study Design

Total Participants: 60
Treatment Group(s): 6
Primary Treatment: Six-minute walk test
Phase:
Study Start date:
October 10, 2024
Estimated Completion Date:
February 29, 2036

Connect with a study center

  • University of Leicester

    Leicester,
    United Kingdom

    Active - Recruiting

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