Using MRI to understand heart failure in patients with preserved ejection fraction and diabetes
Manganese-enhanced Magnetic Resonance Imaging (MEMRI) in Heart Failure With Preserved Ejection Fraction
University of Leicester · NCT06652763
This study is trying to see how heart failure with preserved ejection fraction affects people with type 2 diabetes by using special MRI scans to learn more about their heart's function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester (other) |
| Locations | 1 site (Leicester) |
| Trial ID | NCT06652763 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate heart failure with preserved ejection fraction (HFpEF) in patients, particularly focusing on those with type 2 diabetes. It will utilize manganese-enhanced magnetic resonance imaging (MEMRI) and other assessments to explore the heart's ability to take up calcium and its energy efficiency. By understanding these mechanisms, the study seeks to shed light on the relationship between HFpEF and diabetes, which is currently poorly understood. Participants will undergo various tests, including echocardiograms and MRI scans, to gather comprehensive data on their heart function.
Who should consider this trial
Good fit: Ideal candidates include individuals with symptoms or a diagnosis of heart failure with preserved ejection fraction and type 2 diabetes.
Not a fit: Patients with type 1 diabetes or those with severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of heart failure in patients with preserved ejection fraction and diabetes.
How similar studies have performed: While there is limited research specifically using MEMRI for HFpEF, studies exploring heart function in diabetes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leicester
- University of Leicester — Leicester, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Gerry P McCann, MD — University of Leicester
- Study coordinator: Gerry P McCann, MD
- Email: gpm12@leicester.ac.uk
- Phone: +44 (0)116 258 3038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Preserved Ejection Fraction, Type 2 Diabetes