Evidence map›Paper›PMID 37003987›Full record

Trial reportBMC cardiovascular disorders2023

Effect on cardiac function among patients with type 2 diabetes following high-dose mineralocorticoid receptor antagonist using echocardiography; data from the MIRAD randomized clinical trial.

Niels H Brandt-Jacobsen, Marie Louise Johansen, Jon J Rasmussen, Morten Dalsgaard, Thomas Kumler, Jens Faber, Patrick Rossignol, Morten Schou, Caroline Kistorp

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC cardiovascular disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.4field-weighted citation impact, top 36% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

9 authors at 4 institutions in 3 countries.

Niels H Brandt-JacobsenDepartment of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Marie Louise JohansenDepartment of Endocrinology-Internal Medicine, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.
Jon J RasmussenDepartment of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Morten DalsgaardDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.
Thomas KumlerDepartment of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.
Jens FaberDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Patrick RossignolUniversité de Lorraine, Nancy, France.
Morten SchouDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Caroline KistorpDepartment of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. cnkistorp@dadlnet.dk.
University of Copenhagen · DKGentofte Hospital · DKCopenhagen University Hospital · DKInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEarly heart failure prevention is central in patients with type 2 diabetes, and mineralocorticoid receptor antagonists (MRAs) have shown to improve prognosis. We investigated the effect of high-dose MRA, eplerenone, on cardiac function and structure in patients with type 2 diabetes and established or increased risk of cardiovascular disease but without heart failure.

methodsIn the current randomized, placebo-controlled clinical trial, 140 patients with high-risk type 2 diabetes were randomized to high-dose eplerenone (100-200 mg daily) or placebo as add-on to standard care for 26 weeks. Left ventricular systolic and diastolic function, indexed left ventricular mass (LVMi), and global longitudinal strain (GLS) were assessed using echocardiography at baseline and after 26 weeks of treatment.

resultsOf the included patients, 138 (99%) had an echocardiography performed at least once. Baseline early diastolic in-flow velocity (E-wave) indexed by mitral annulus velocity (e') was mean (SD) 11.1 (0.5), with 31% of patients reaching above 12. No effect of treatment on diastolic function was observed measured by E/e' (0.0, 95%CI [-1.2 to 1.2], P = 0.992) or E/A (-0.1, 95%CI [-0.2 to 0.0], P = 0.191). Mean left ventricular ejection fraction (LVEF) at baseline was 59.0% (8.0). No improvement in systolic function was observed when comparing groups after 26 weeks (LVEF: 0.9, 95%CI [-1.1 to 2.8], P = 0.382; GLS: -0.4%, 95%CI [-1.5 to 0.6], P = 0.422), nor in LVMi (-3.8 g/m

conclusionIn the present echo sub-study, no change in left ventricular function was observed following high-dose MRA therapy in patients with type 2 diabetes when evaluated by conventional echocardiography.

trial registrationDate of registration 25/08/2015 (EudraCT number: 2015-002,519-14).

Indexed as

Diabetes Mellitus, Type 2Heart FailureVentricular Dysfunction, LeftEchocardiographyEplerenoneHumansMineralocorticoid Receptor AntagonistsStroke VolumeVentricular Function, LeftEplerenoneMineralocorticoid Receptor AntagonistsGlobal longitudinal strainHigh-dose eplerenoneMineralocorticoid receptor antagonistSystolic and diastolic function

Identifiers

PMID37003987
PMCPMC10064675
OpenAlexW4362467483

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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 OpenQuestion graph.