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.


Journal

BMC cardiovascular disorders
ISSN: 1471-2261
Titre abrégé: BMC Cardiovasc Disord
Pays: England
ID NLM: 100968539

Informations de publication

Date de publication:
31 03 2023
Historique:
received: 18 02 2022
accepted: 14 03 2023
medline: 4 4 2023
entrez: 2 4 2023
pubmed: 3 4 2023
Statut: epublish

Résumé

Early 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. In 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. Of 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 In 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. Date of registration 25/08/2015 (EudraCT number: 2015-002,519-14).

Sections du résumé

BACKGROUND
Early 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.
METHODS
In 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.
RESULTS
Of 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
CONCLUSION
In 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 REGISTRATION
Date of registration 25/08/2015 (EudraCT number: 2015-002,519-14).

Identifiants

pubmed: 37003987
doi: 10.1186/s12872-023-03183-1
pii: 10.1186/s12872-023-03183-1
pmc: PMC10064675
doi:

Substances chimiques

Mineralocorticoid Receptor Antagonists 0
Eplerenone 6995V82D0B

Types de publication

Randomized Controlled Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

175

Informations de copyright

© 2023. The Author(s).

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Auteurs

Niels H Brandt-Jacobsen (N)

Department of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Marie Louise Johansen (ML)

Department of Endocrinology-Internal Medicine, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.

Jon J Rasmussen (JJ)

Department of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.

Morten Dalsgaard (M)

Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.

Thomas Kumler (T)

Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.

Jens Faber (J)

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Endocrinology-Internal Medicine, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.

Patrick Rossignol (P)

Université de Lorraine, Nancy, France.
Department de Défaillance Cardiovasculaire Aiguë et Chronique, L'Institut National de la Santé et de la Recherche Médicale (URM-S 116), Nancy, France.
Centre Hospitalier Régional Universitaire, Nancy, France.
French Clinical Research Infrastructure Network Investigation Network Initiative - Cardiovascular and Renal Clinical Trialists, Nancy, France.
Centre d'Investigation Clinique Plurithématique 1433, L'Institut National de la Santé et de la Recherche Médicale, Nancy, France.

Morten Schou (M)

Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte Hospital, Herlev, Denmark.

Caroline Kistorp (C)

Department of Endocrinology, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark. cnkistorp@dadlnet.dk.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. cnkistorp@dadlnet.dk.

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