NCT06652763Recruiting
Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- 10 Oct 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- University of Leicester
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT06652763
What you commit to
- Study type: Observational
- Planned participants: 60
- From 10 Oct 2024 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving an investigational drug or device within 30 days prior to participating in the study
- Recent myocardial infarction within the previous 3 months
Other illness
- Known diagnosis of Type 1 Diabetes
- Decompensated heart failure or pulmonary oedema
- Abnormal liver function tests (\> 3x upper limit of normal) or history of liver disease
- Severe native valve disease, restrictive cardiomyopathy, constrictive pericarditis or hypertrophic cardiomyopathy, myocarditis or takotsubo cardiomyopathy.
Lab values
- History of prolonged corrected QT interval or torsades de pointes
- Baseline eGFR \< 30mL/min/1.73m2
Age
- Pregnancy or breast-feeding or females of child bearing age without a negative pregnancy test
Other
- Second- or third-degree atrioventricular block
- Any contraindications to MRI including implanted devices/pacemakers
- Known diagnosis of pheochromocytoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Leicester Coordinator of this site? Confirm its status | Leicester | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.