A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of immunosuppression in biopsy-proven virus-negative myocarditis or inflammatory cardiomyopathy (IMPROVE-MC)

Ozierański, Krzysztof; Tymińska, Agata; Marchel, Michał; Januszkiewicz, Łukasz; Maciejewski, Cezary; Główczyńska, Renata; Marcolongo, R; Wojnicz, Romuald; Mizia‐Stec, Katarzyna; Grzybowski, Jacek; Gąsior, Mariusz; Nowalany-Kozielska, Ewa; Pawlak, Agnieszka; Kaczmarek, Krzysztof; Żegarska, Jolanta; Pączek, Leszek; Balsam, Paweł; Opolski, Grzegorz; Grabowski, Marcin

doi:10.5603/cj.a2021.0166

Cited by 6 publications

(5 citation statements)

References 23 publications

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“…However, further, randomized controlled studies are needed to explain the efficacy and safety of the immunosuppressive therapy in myocarditis. At present a multicenter, double blind randomized trial (IMPROVE-MC) on combined 12-month therapy of azathioprine with prednisone is ongoing in Poland [ 59 , 60 ].…”

Section: Treatment Optionsmentioning

confidence: 99%

Advances in myocarditis management in the light of the latest research and recent guidelines of the European Society of Cardiology

Chabior,

Tymińska,

Pawlak

et al. 2024

Cardiol J.

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Myocarditis remains an unknown disease with varying clinical manifestations, often leading to heart failure. The latest 2021 and 2022 guidelines of the European Society of Cardiology (ESC) are the first official European documents updating knowledge on the diagnosis and treatment of myocarditis since the 2013 ESC expert consensus statement. These guidelines and new studies allow standardization and improvements to the management of myocarditis. In this review, we discuss the most important aspects of myocarditis diagnosis, therapies and follow-up based on current knowledge.

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Section: Treatment Optionsmentioning

confidence: 99%

Advances in myocarditis management in the light of the latest research and recent guidelines of the European Society of Cardiology

Chabior,

Tymińska,

Pawlak

et al. 2024

Cardiol J.

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“…Further multicentre randomized trials addressing this topic are certainly needed. Results from ongoing randomized studies such as MYTHS trial (NCT05150704) or IMPROVE‐MC are awaited 15 …”

Section: Frustaci Et Al7 Merken Et Al8 Peretto Et Al9 Caforio Et Al10mentioning

confidence: 99%

Tailored immunosuppression in biopsy‐proven immune‐mediated myocarditis

Kuchynka,

Krejci,

Palecek

2024

European J of Heart Fail

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This article refers to 'Long-term efficacy and safety of tailored immunosuppressive therapy in immune-mediated biopsy-proven myocarditis: A propensity-weighted study' by A.L.P. Caforio et al., published in this issue on pages 1175-1185.Myocarditis is an inflammatory disease of the myocardium that may occur as a consequence of infection, exposure to a toxic substance, and immune system activation. 1 It has a wide spectrum of clinical manifestations ranging from chest pain, dyspnoea, palpitations, or fatigue, to life-threatening conditions such as cardiogenic shock and malignant arrhythmias. Endomyocardial biopsy (EMB) confirms the diagnosis of myocarditis, reveals the type of inflammation (lymphocytic, eosinophilic, giant-cell, or granulomatous), and helps to identify underlying aetiology. 2 Due to its invasive nature and non-negligible risk of potential complications, EMB is indicated only in specific clinical scenarios such as suspected fulminant myocarditis, persistent left ventricular (LV) dysfunction, worsening heart failure, or arrhythmias as listed in a recent position statement of the Heart Failure Association of the European Society of Cardiology (ESC), the Heart Failure Society of America, and the Japanese Heart Failure Society. 3 Based on a position statement published by the ESC Working Group on Myocardial and Pericardial Diseases, immunosuppressive (IS) treatment should be considered in proven autoimmune forms of myocarditis including giant-cell myocarditis, cardiac sarcoidosis, myocarditis associated with known extra-cardiac autoimmune diseases, and in patients with eosinophilic or toxic myocarditis with heart failure or arrhythmias. 2 Immunosuppression may be also considered in lymphocytic myocarditis refractory to standard therapy. 2 In all of these scenarios it is advised to start IS therapy after ruling out active infection on EMB by polymerase chain reaction (PCR). The rationale to exclude infection is based on conflicting evidence for IS treatment from randomized trials in which PCR focused on viral agents was not performed. In the Myocarditis Treatment Trial, which included 111 patients with a histopathological diagnosis of myocarditis using the Dallas criteria 4 and LV ejection fraction (LVEF) <45%, treatmentThe opinions expressed in this article are not necessarily those of the Editors of the European Journal of Heart Failure or of the European Society of Cardiology.

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“…As such, corticosteroid therapy combined with the use corticosteroid-sparing agent is the most used first-line therapy regimen and should be tailored depending on patient characteristics (e.g., underlying autoimmune disease) [ 139 ]. There are ongoing clinical trials that may provide randomized multicenter evidence for the use of immunosuppressive treatment in the future [ 171 ]. Immunosuppressive therapy in myocarditis should be considered not only after confirmation of the absence of a viral genome on EMB, but also after an exhaustive search for potential contraindications to the treatment itself.…”

Section: Autoimmune Myocarditis and Drug-induced Myocarditismentioning

confidence: 99%

Myocarditis: Etiology, Pathogenesis, and Their Implications in Clinical Practice

Brociek

Tymińska

Giordani

et al. 2023

Biology

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Myocarditis is an inflammatory disease of the myocardium caused by infectious or non-infectious agents. It can lead to serious short-term and long-term sequalae, such as sudden cardiac death or dilated cardiomyopathy. Due to its heterogenous clinical presentation and disease course, challenging diagnosis and limited evidence for prognostic stratification, myocarditis poses a great challenge to clinicians. As it stands, the pathogenesis and etiology of myocarditis is only partially understood. Moreover, the impact of certain clinical features on risk assessment, patient outcomes and treatment options is not entirely clear. Such data, however, are essential in order to personalize patient care and implement novel therapeutic strategies. In this review, we discuss the possible etiologies of myocarditis, outline the key processes governing its pathogenesis and summarize best available evidence regarding patient outcomes and state-of-the-art therapeutic approaches.

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A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of immunosuppression in biopsy-proven virus-negative myocarditis or inflammatory cardiomyopathy (IMPROVE-MC)

Abstract: This article has been peer reviewed and published immediately upon acceptance.It is an open access article, which means that it can be downloaded, printed, and distributed freely, provided the work is properly cited. Articles in "Cardiology Journal" are listed in PubMed.

Cited by 6 publications

References 23 publications

Advances in myocarditis management in the light of the latest research and recent guidelines of the European Society of Cardiology

Advances in myocarditis management in the light of the latest research and recent guidelines of the European Society of Cardiology

Tailored immunosuppression in biopsy‐proven immune‐mediated myocarditis

Myocarditis: Etiology, Pathogenesis, and Their Implications in Clinical Practice

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