At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Minnesota Living with Heart Failure Questionnaire (other), Echocardiogram (diagnostic test), Six-minute walk test (diagnostic test), Manganese-enhanced MRI and 31-P magnetic resonance spectroscopy (diagnostic test)
- How long the study runs
- Study runs about 136 months (dates as stated)
- About the drug or intervention
- 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. · 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2024-10-10
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure with preserved ejection fraction
- • Clinical study - 60 participants
- • Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart cannot fill with blood effectively
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure with preserved ejection fraction
Where?
- • Leicester - University of Leicester
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Capacity to provide agreement to take part
Who cannot take part
- ✗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 lung oedema
- ✗History of prolonged corrected QT interval or torsades de pointes
See the full criteria
Where Is This Study? (1 UK site)
University of Leicester
Leicester, United Kingdom
How to Get in Touch
Gerry P McCann, MD
Sponsor contactCONTACT
Abhishek Dattani, MBBS
Sponsor contactCONTACT