Does Dapagliflozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?

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.

Conditions

• Type 2 Diabetes
• Left Ventricular Hypertrophy

Interventions

DRUG

Dapagliflozin

SGLT2 inhibitor

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

• NHS Tayside

  collaborator OTHER_GOV

• AstraZeneca

  collaborator INDUSTRY

• University of Dundee

  lead OTHER

Principal Investigators

• Allan Struthers, MD, FRCP · University of Dundee

• Chim Lang, MD, FRCP · University of Dundee

• Graeme Houston, FRCR, MBBCh · University of Dundee

• Rory McCrimmon, MBChB, MRCP · University of Dundee

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-14

Primary Completion

2019-03-14

Completion

2019-04-02

Countries

• United Kingdom

Study Locations