Using MRI to understand heart failure in patients with preserved ejection fraction and diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.