Heart Failure With Preserved Ejection FractionMEMRI in HFpEFNCT06652763
Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes
- What is being tested?
- Minnesota Living with Heart Failure Questionnaire, Echocardiogram and Six-minute walk test
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2024to Feb 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary and secondary care patients
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abhishek Dattani, MBBS contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leicester
Leicester
Gerry P McCann, MD, 0116 2583038, gpm12@leicester.ac.uk
Abhishek Dattani, MBBS, ad530@leicester.ac.uk
About this study
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.
- Being tested
- Minnesota Living with Heart Failure Questionnaire, Echocardiogram, Six-minute walk test, Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy, Cardiovascular magnetic resonance scan
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minnesota Living with Heart Failure QuestionnaireOther
Self-administered, validated questionnaire to assess symptoms of heart failure
EchocardiogramDiagnostic 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 testDiagnostic test
Standardised, objective assessment of exercise capacity
Manganese-enhanced MRI and 31-P magnetic resonance spectroscopyDiagnostic 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 scanDiagnostic test
Scan including adenosine stress perfusion
Blood testsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| HFpEF with T2D | Participants with heart failure with preserved ejection fraction and type 2 diabetes Receives: 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 | |
| HFpEF without T2D | Participants with heart failure with preserved ejection fraction but without type 2 diabetes Receives: 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 | |
| Controls | Healthy volunteers without heart failure or type 2 diabetes Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki
Manganese influx constant as measured by MEMRI scan
Measured: Baseline
Secondary outcomes (14)
T1 values
T1 values measured at 30 minutes post contrast on MEMRI scan
Measured: Baseline
Myocardial PCr/ATP ratio
Phosphocreatine-to-ATP ratio as measured by 31P-magnetic resonance spectroscopy
Measured: Baseline
Left ventricular ejection fraction
%, measured by CMR
Measured: Baseline
LV global longitudinal strain
%, measured by CMR
Measured: Baseline
LV global circumferential strain
%, measured by CMR
Measured: Baseline
LV PEDSR
1/s, measured by CMR
Measured: Baseline
LV mass
grams, measured by CMR
Measured: Baseline
LV mass/volume ratio
Measured by CMR
Measured: Baseline
Myocardial fibrosis
CMR assessed markers of LV myocardial fibrosis (extracellular volume)
Measured: Baseline
Myocardial Perfusion
CMR assessed markers of perfusion (myocardial perfusion reserve)
Measured: Baseline
Associations of Ki with resting PCr/ATP
Univariate and multivariate models to look for association between Ki and PCr/ATP ratio
Measured: 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.
Measured: 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
Measured: Baseline
10-year outcomes
10-year outcomes including HF hospitalisation (time to first event and cumulative) and all-cause death.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start10 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionFeb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerry P McCann, MD, Principal investigator, University of LeicesterAbhishek Dattani, MBBS, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652763
- Sponsor's protocol ID
- 0883
- Acronym
- MEMRI in HFpEF
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06652763
- Acronym / sponsor ID
- MEMRI in HFpEF / 0883
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Feb 2036 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HFpEF with T2D | – | 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 testsParticipants with heart failure with preserved ejection fraction and type 2 diabetes |
| HFpEF without T2D | – | 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 testsParticipants with heart failure with preserved ejection fraction but without type 2 diabetes |
| Controls | – | 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 testsHealthy volunteers without heart failure or type 2 diabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary and secondary care patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minnesota Living with Heart Failure QuestionnaireSelf-administered, validated questionnaire to assess symptoms of heart failure | Other | Controls, HFpEF with T2D, HFpEF without T2D |
| EchocardiogramResting transthoracic echocardiogram to exclude valvular pathology and the assess indices of systolic and diastolic function and speckle tracking for strain | Diagnostic test | Controls, HFpEF with T2D, HFpEF without T2D |
| Six-minute walk testStandardised, objective assessment of exercise capacity | Diagnostic test | Controls, HFpEF with T2D, HFpEF without T2D |
| Manganese-enhanced MRI and 31-P magnetic resonance spectroscopyUsing 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 test | Controls, HFpEF with T2D, HFpEF without T2D |
| Cardiovascular magnetic resonance scanScan including adenosine stress perfusion | Diagnostic test | Controls, HFpEF with T2D, HFpEF without T2D |
| Blood testsFull 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 | Diagnostic test | Controls, HFpEF with T2D, HFpEF without T2D |
Primary outcome
Ki
Time frame: Baseline
Manganese influx constant as measured by MEMRI scan
14 secondary outcomes
T1 values
Time frame: Baseline
Myocardial PCr/ATP ratio
Time frame: Baseline
Left ventricular ejection fraction
Time frame: Baseline
LV global longitudinal strain
Time frame: Baseline
LV global circumferential strain
Time frame: Baseline
LV PEDSR
Time frame: Baseline
LV mass
Time frame: Baseline
LV mass/volume ratio
Time frame: Baseline
Myocardial fibrosis
Time frame: Baseline
Myocardial Perfusion
Time frame: Baseline
Associations of Ki with resting PCr/ATP
Time frame: Baseline
Associations of exercise capacity with Ki and PCr/ATP in HFpEF
Time frame: Baseline
Plasma biomarkers of metabolic dysregulation, fibrosis and inflammation
Time frame: Baseline
10-year outcomes
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abhishek Dattani, MBBS contact
Gerry P McCann, MD principal investigator
University of Leicester
Abhishek Dattani, MBBS principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Type 2 Diabetes, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerry P McCann, MD (+44 (0)116 258 3038, gpm12@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ki (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.