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NCT Number: NCT06652763

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

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Leicester

Leicester, United Kingdom

Location status: Recruiting

Location contact

Abhishek Dattani, MBBS

CONTACT

[email protected]

Abhishek Dattani, MBBS

SUB_INVESTIGATOR

Gaurav S Gulsin, PhD

SUB_INVESTIGATOR

Gerry P McCann, MD

CONTACT

[email protected]

0116 2583038

Gerry P McCann, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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) 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

Exclusion criteria

  • 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
  • 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 liver disease
  • Baseline eGFR < 30mL/min/1.73m2
  • Any contraindications to MRI including implanted devices/pacemakers
  • Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.
  • Recent myocardial infarction within the previous 3 months
  • Known diagnosis of pheochromocytoma

Treatment and study plan

Minnesota Living with Heart Failure Questionnaire

Other

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

Primary outcomes

  1. Ki

    Time frame: Baseline

    Manganese influx constant as measured by MEMRI scan

Secondary outcomes

  1. T1 values

    Time frame: Baseline

    T1 values measured at 30 minutes post contrast on MEMRI scan

  2. Myocardial PCr/ATP ratio

    Time frame: Baseline

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

  3. Left ventricular ejection fraction

    Time frame: Baseline

    %, measured by CMR

  4. LV global longitudinal strain

    Time frame: Baseline

    %, measured by CMR

  5. LV global circumferential strain

    Time frame: Baseline

    %, measured by CMR

  6. LV PEDSR

    Time frame: Baseline

    1/s, measured by CMR

  7. LV mass

    Time frame: Baseline

    grams, measured by CMR

  8. LV mass/volume ratio

    Time frame: Baseline

    Measured by CMR

  9. Myocardial fibrosis

    Time frame: Baseline

    CMR assessed markers of LV myocardial fibrosis (extracellular volume)

  10. Myocardial Perfusion

    Time frame: Baseline

    CMR assessed markers of perfusion (myocardial perfusion reserve)

  11. Associations of Ki with resting PCr/ATP

    Time frame: Baseline

    Univariate and multivariate models to look for association between Ki and PCr/ATP ratio

  12. Associations of exercise capacity with Ki and PCr/ATP in HFpEF

    Time frame: Baseline

    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.

  13. Plasma biomarkers of metabolic dysregulation, fibrosis and inflammation

    Time frame: Baseline

    This exploratory outcome will assess the differences in a wide range of plasma biomarkers between groups and their association with Ki

  14. 10-year outcomes

    Time frame: Baseline

    10-year outcomes including HF hospitalisation (time to first event and cumulative) and all-cause death.

Study contacts

Contact information is provided by the study sponsor or research team.

Abhishek Dattani, MBBS

CONTACT

[email protected]

Gerry P McCann, MD

CONTACT

[email protected]

+44 (0)116 258 3038

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Registry information

Acronym: MEMRI in HFpEF

Important dates

Study start
2024
Primary completion
2026
Study completion
2036
First posted
Oct 22, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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