Evidence map›Paper›PMID 28835229›Full record

Trial reportBMC cardiovascular disorders2017

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

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cardiovascular disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02956811. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02956811 phase4completed

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

Ran2017Enrolled66Registered outcomes14Posted comparisons0ConditionsLeft Ventricular Hypertrophy, Type 2 DiabetesArmsdapagliflozin, Placebo
Open the trial in the graph
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  18. The Pleiotropic Effects of Sodium-Glucose Cotransporter-2 Inhibitors: Beyond the Glycemic Benefit.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2019
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Alexander J M BrownCardiovascular Medicine, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, Dundee, DD1 9SY, UK.
Chim LangCardiology, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, Dundee, DD1 9SY, UK.
Rory McCrimmonExperimental Diabetes and Metabolism, Division of Molecular and Clinical Medicine, School of Medicine, Level 5, Ninewells Hospital and Medical School, Mailbox 12, Dundee, DD1 9SY, UK.
Allan StruthersCardiovascular Medicine and Therapeutics, Division of Molecular and Clinical Medicine, Medical Research Institute, Ninewells Hospital and Medical School, Mailbox 2, Dundee, DD1 9SY, UK. a.d.struthers@dundee.ac.uk.ORCID 0000-0002-2926-2528

Funding

British Heart Foundation PG/14/4/30539British Heart Foundation PG/16/32/32132Medical Research Council G0701592
6 · The paper itself

Abstract

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. 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 registrationClinical Trials.gov: NCT02956811 . Registered November 2016.

Indexed as

Administration, OralBenzhydryl CompoundsBlood Pressure Monitoring, AmbulatoryClinical ProtocolsDiabetes Mellitus, Type 2Diabetic CardiomyopathiesDisease ProgressionDouble-Blind MethodGlucosidesHumansHypertrophy, Left VentricularHypoglycemic AgentsMagnetic Resonance ImagingProof of Concept StudyProspective StudiesResearch DesignBenzhydryl CompoundsdapagliflozinGlucosidesHypoglycemic AgentsCardiac MRIDiabetesLeft ventricular hypertrophyMechanistic trialSGLT2 inhibitor

Identifiers

PMID28835229
PMCPMC5569551

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.