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Randomized Controlled Trial
. 2017 Aug 23;17(1):229.
doi: 10.1186/s12872-017-0663-6.

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

Alexander J M Brown  1 , Chim Lang  2 , Rory McCrimmon  3 , Allan Struthers  4
Affiliations
Randomized Controlled Trial

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

Alexander J M Brown et al. BMC Cardiovasc Disord. .

Abstract

Background: Patients 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).

Methods: The 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.

Discussion: This 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 registration: Clinical Trials.gov: NCT02956811 . Registered November 2016.

Keywords: Cardiac MRI; Diabetes; Left ventricular hypertrophy; Mechanistic trial; SGLT2 inhibitor.

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Conflict of interest statement

Ethics approval and consent to participate

The study has been granted ethics approval by the East of Scotland Research Ethics Service [16/ES/0131].

Consent for publication

This article does not contain any individual person’s data thus consent for publication is not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design flowchart. SDRN Scottish Diabetes Research Network; SPRN Scottish Primary Research Network; MRI Magnetic Resonance Imaging; BP Blood Pressure; BMI: Body Mass Index
Fig. 2
Fig. 2
DAPA LVH trial hypothesis. The above figure explains the hypothesis of the DAPALVH trial where reduction in preload and afterload, weight and insulin resistance will all contribute to regression of left ventricular hypertrophy. This will be measured by cardiac MRI. BNP: B Type Natriuretic Peptide; BP: Blood Pressure; EDV: End Diastolic Volume; FIRI: Fasting Insulin Resistance Index; HBA1C: Glycosylated Haemoglobin; IVRT: Isovolumetric Relaxation Time; LA: Left Atrial; LV: Left Ventricular; LVEF: Left Ventricular Ejection Fraction; LVH: Left Ventricular Hypertrophy; MRI: Magnetic Resonance Imaging
See this image and copyright information in PMC

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