Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
Status:
Completed
Trial end date:
2019-04-02
Target enrollment:
Participant gender:
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 (BP). 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. This trial will investigate the ability of dapagliflozin to regress LVH in 64
participants with normotensive diabetes. This will be done by seeing if dapagliflozin reduces
left ventricular mass as measured by cardiac magnetic resonance imaging (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 MRI will be performed at baseline and
at 12 months, this 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.