DAPA MEMRI
Research type
Research Study
Full title
An observational cross-sectional study and a double blind placebo controlled randomised controlled trial to assess the effect of dapaglifozin on myocardial calcium handling in patients with heart failure
IRAS ID
276816
Contact name
David Newby
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across the heart muscle and disruption of this process is an early change seen in heart failure. Recently, a drug therapy (SGLT2 inhibitors) in patients with diabetes was shown to benefit patients with heart failure but the mechanisms of benefit is unknown.
Our hypothesis is that calcium handling is altered in patients with either type 2 diabetes mellitus (T2DM) or heart failure and that SGLT2 inhibitors can improve this in heart failure irrespective of the presence of T2DM.
Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function by using a new contrast ‘dye' containing manganese that has shown advantages over traditional contrast. We plan to further test this new dye as it has the potential to track and quantify improvements in heart function over time and detect changes in calcium handling in the heart muscle, making it an ideal measure to identify the mechanisms of benefit from SGLT2i therapy.
The study population will comprise patients with heart failure with and without T2DM, patients with T2DM without heart failure and normal healthy volunteers. Baseline comparisons will be made between the four groups before progressing to the randomised controlled trial with heart failure patients only. Patients will have a clinical assessment and blood tests, electrocardiogram, echocardiogram and MRI of the heart at each visit.If successful, this study will give us significant insights into mechanism of action of SGLT2 inhibitors in heart failure and will enable us to tailor specific treatments in heart failure patients.
REC name
North of Scotland Research Ethics Committee 2
REC reference
20/NS/0037
Date of REC Opinion
30 Mar 2020
REC opinion
Further Information Favourable Opinion