DAPA-LVH Trial
Research type
Research Study
Full title
Does Dapaglifozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
IRAS ID
208264
Contact name
Alex Brown
Contact email
Sponsor organisation
University of Dundee
Eudract number
2016-000715-33
Duration of Study in the UK
2 years, 3 months, 5 days
Research summary
Left ventricular hypertrophy (LVH) is common in people with type 2 diabetes (70%) and is the strongest independent risk factor for cardiovascular events and all-cause mortality that there is. It is worse than triple vessel coronary disease. LVH often occurs in patients with “normal” blood pressures. Apart from BP, the other three main factors causing LVH are insulin resistance, obesity and cardiac preload. Dapagliflozin reduces ALL four factors known to promote LVH i.e. Dapagliflozin reduces weight, glycaemia, preload and blood pressure and is therefore the ideal agent to reduce LVH since it uniquely attacks all four known mediators of LVH. In this trial, we will investigate the ability of dapagliflozin to regress LVH in 64 participants with normotensive diabetes. We will do this by seeing if dapagliflozin reduces left ventricular mass as measured by cardiac MRI. This trial may identify a novel way to reduce the strong independent risk factor of LVH which often persists despite optimum medical therapy in patients with diabetes. If dapagliflozin does reduce LVH, this would be a key sign of which subgroup of patients with diabetes (those with LVH) should be especially targeted with dapagliflozin.
64 participants with type 2 diabetes and LVH will be recruited through the Scottish Diabetes Research Network (SDRN), Scottish Primary Care Research Network (SPCRN) and other routes, in this single centre study. Participants will be randomised to receive either 10mg dapagliflozin or placebo daily for 12 months. Cardiac Magnetic Resonance Imaging (MRI) will be performed at baseline and at 12 months, these will be assessed for the primary outcome of change in left ventricular mass. Secondary outcomes will examine change in 24 hour blood pressure and weight.REC name
East of Scotland Research Ethics Service REC 2
REC reference
16/ES/0131
Date of REC Opinion
19 Dec 2016
REC opinion
Further Information Favourable Opinion