Does dapagliflozin regress left ventricular hypertrophy in patients with type 2 diabetes? A prospective, double-blind, randomised, placebo-controlled study

BMC Cardiovascular Disorders

Study Protocol

Chim Lang¹  Allan Struthers²  Alexander J.M. Brown³  Rory McCrimmon⁴ 

[1] Cardiology, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, DD1 9SY, Dundee, UK;Cardiovascular Medicine and Therapeutics, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, DD1 9SY, Dundee, UK;Cardiovascular Medicine, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, DD1 9SY, Dundee, UK;Experimental Diabetes and Metabolism, Division of Molecular and Clinical Medicine, School of Medicine, Level 5, Ninewells Hospital and Medical School, Mailbox 12, DD1 9SY, Dundee, UK;

关键词: Diabetes;    SGLT2 inhibitor;    Left ventricular hypertrophy;    Mechanistic trial;    Cardiac MRI;   

DOI  :  10.1186/s12872-017-0663-6

 received in 2017-05-16, accepted in 2017-08-16,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPatients with diabetes have a two to fourfold increased risk for development of and death from cardiovascular disease [CVD]. The current oral hypoglycaemic agents result in limited reduction in this cardiovascular risk. Sodium glucose linked co-transporter type 2 [SGLT2] inhibitors are a relatively new class of antidiabetic agent that have been shown to have potential cardiovascular benefits. In support of this, the EMPA-REG trial showed a striking 38% and 35% reduction in cardiovascular mortality and heart failure [HF] hospitalisation respectively. The exact mechanism (s) responsible for these effects remain (s) unclear. One potential mechanism is regression of Left ventricular hypertrophy (LVH).MethodsThe DAPA-LVH trial is a prospective, double-blind, randomised, placebo-controlled ‘proof of concept’ single-centre study that has been ongoing since January 2017. It is designed specifically to assess whether the SGLT2 inhibitor dapagliflozin regresses left ventricular [LV] mass in patients with diabetes and left ventricular hypertrophy [LVH]. We are utilising cardiac and abdominal magnetic resonance imaging [MRI] and ambulatory blood pressure monitoring to quantify the cardiovascular and systemic effects of dapagliflozin 10 mg once daily against standard care over a 1 year observation period. The primary endpoint is to detect the changes in LV mass. The secondary outcomes are to assess the changes in, LV volumes, blood pressure, weight, visceral and subcutaneous fat.DiscussionThis trial will be able to determine if SGLT2 inhibitor therapy reduces LV mass in patient with diabetes and LVH thereby strengthening their position as oral hypoglycaemic agents with cardioprotective benefits.Trial registrationClinical Trials.gov: NCT02956811. Registered November 2016.

【 授权许可】

CC BY   
© The Author(s). 2017