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

Alexander J. M. Brown; Chim Lang; Rory McCrimmon; Allan Struthers

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, Chim Lang, Rory McCrimmon, Allan Struthers (Lead / Corresponding author)

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	229
Pages (from-to)	1-12
Number of pages	12
Journal	BMC Cardiovascular Disorders
Volume	17
DOIs	https://doi.org/10.1186/s12872-017-0663-6
Publication status	Published - 23 Aug 2017

Keywords

Diabetes
SGLT2 inhibitor
Left ventricular hypertrophy
Mechanistic trial
Cardiac MRI

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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© The Author(s). 2017. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Final published version, 1.04 MBLicence: CC BY

REnal and Cardiovascular Effects of SGLT2 Inhibition in Combination with Loop DiurEtics in Diabetic Patients with Chronic Heart Failure (RECEDE-CHF)
Lang, C. (Investigator), McCrimmon, R. (Investigator), Mordi, I. (Investigator), Singh, J. (Investigator) & Struthers, A. (Investigator)
British Heart Foundation
29/07/16 → 28/01/19
Project: Research

McCrimmon, Rory
Person

Tayside Clinical Trials Unit
Health and Clinical Services
Facility/equipment: Facility

Cite this

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

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 = "Diabetes, SGLT2 inhibitor, Left ventricular hypertrophy, Mechanistic trial, Cardiac MRI",

author = "Brown, \{Alexander J. M.\} and Chim Lang and Rory McCrimmon and Allan Struthers",

note = "This study is funded by Astra Zeneca",

year = "2017",

month = aug,

day = "23",

doi = "10.1186/s12872-017-0663-6",

language = "English",

volume = "17",

pages = "1--12",

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T1 - Does dapagliflozin regress left ventricular hypertrophy in patients with type 2 diabetes?

T2 - A prospective, double-blind, randomised, placebo-controlled study

AU - Brown, Alexander J. M.

AU - Lang, Chim

AU - McCrimmon, Rory

AU - Struthers, Allan

N1 - This study is funded by Astra Zeneca

PY - 2017/8/23

Y1 - 2017/8/23

N2 - 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.

AB - 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.

KW - Diabetes

KW - SGLT2 inhibitor

KW - Left ventricular hypertrophy

KW - Mechanistic trial

KW - Cardiac MRI

U2 - 10.1186/s12872-017-0663-6

DO - 10.1186/s12872-017-0663-6

M3 - Article

C2 - 28835229

SN - 1471-2261

VL - 17

SP - 1

EP - 12

JO - BMC Cardiovascular Disorders

JF - BMC Cardiovascular Disorders

M1 - 229

ER -

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

Abstract

Keywords

UN SDGs

Access to Document

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Projects

REnal and Cardiovascular Effects of SGLT2 Inhibition in Combination with Loop DiurEtics in Diabetic Patients with Chronic Heart Failure (RECEDE-CHF)

Profiles

McCrimmon, Rory

Equipment

Tayside Clinical Trials Unit

Cite this