MYOFLAME-19 RCT 的设计和原理:使用 CMR终点对心肌进行保护,以减少 COVID-19 感染引起的心肌炎性心脏病。

IF 4.2 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Valentina O Puntmann, Dietrich Beitzke, Andreas Kammerlander, Inga Voges, Dominik D Gabbert, Marcus Doerr, Bishwas Chamling, Biykem Bozkurt, Juan Carlos Kaski, Erica Spatz, Eva Herrmann, Gernot Rohde, Philipp DeLeuw, Lenka Taylor, Christine Windemuth-Kieselbach, Cornelia Harz, Marta Santiuste, Laura Schoeckel, Juliana Hirayama, Peter C Taylor, Colin Berry, Eike Nagel
{"title":"MYOFLAME-19 RCT 的设计和原理:使用 CMR终点对心肌进行保护,以减少 COVID-19 感染引起的心肌炎性心脏病。","authors":"Valentina O Puntmann, Dietrich Beitzke, Andreas Kammerlander, Inga Voges, Dominik D Gabbert, Marcus Doerr, Bishwas Chamling, Biykem Bozkurt, Juan Carlos Kaski, Erica Spatz, Eva Herrmann, Gernot Rohde, Philipp DeLeuw, Lenka Taylor, Christine Windemuth-Kieselbach, Cornelia Harz, Marta Santiuste, Laura Schoeckel, Juliana Hirayama, Peter C Taylor, Colin Berry, Eike Nagel","doi":"10.1016/j.jocmr.2024.101121","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cardiac symptoms due to postacute inflammatory cardiac involvement affect a broad segment of previously well people with only mild acute COVID-19 illness and without overt structural heart disease. Cardiac magnetic resonance (CMR) imaging can identify the underlying subclinical disease process, which is associated with chronic cardiac symptoms. Specific therapy directed at reducing postacute cardiac inflammatory involvement prior to development of myocardial injury and impairment is missing.</p><p><strong>Trial design: </strong>Prospective multicentre randomised placebo-controlled study of myocardial protection therapy (combined immunosuppressive/antiremodelling) of low-dose prednisolone and losartan. Consecutive symptomatic individuals with a prior COVID-19 infection, no preexisting significant comorbidities or structural heart disease, undergo standardised assessments with questionnaires, CMR imaging and cardiopulmonary exercise testing (CPET). Eligible participants fulfilling the criteria of subclinical Post-COVID inflammatory involvement on baseline CMR examination are randomised to treatment with either verum or placebo for a total of 16 weeks (W16). Participants and investigators remain blinded to the group allocation throughout the study duration. The primary efficacy endpoint is the absolute change of left ventricular ejection fraction (LVEF) to baseline at W16, measured by CMR, between the verum treatment and placebo group by absolute difference, using unpaired t-test confirmatively at the 5% significance level. Secondary endpoints include assessment of changes of symptoms, CMR parameters, and CPET after W16, and frequency of major adverse cardiac events after 1 year. Safety data will be analysed for frequency, severity and types of adverse events (AEs) for all treatment groups. The proportion of AEs related to the contrast agent gadobutrol will also be analysed. A calculated sample size is a total of 280 participants (accounting for 8% drop-out), randomised in 1:1 fashion to 140 in the verum and 140 placebo group.</p><p><strong>Conclusion: </strong>Myoflame-19 study will examine the efficacy of a myocardial protection therapy in symptomatic participants with post-COVID inflammatory cardiac involvement determined by CMR. The aim of the intervention is to reduce the symptoms and inflammatory myocardial injury, to improve exercise tolerance and preclude the development of cardiac impairment.</p><p><strong>Clinical trial identifier: </strong>NCT05619653.</p>","PeriodicalId":15221,"journal":{"name":"Journal of Cardiovascular Magnetic Resonance","volume":" ","pages":"101121"},"PeriodicalIF":4.2000,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Design and Rationale of MYOFLAME-19 RCT: MYOcardial protection to reduce inFLAMmatory heart disease due to COVID-19 Infection using CMR Endpoints.\",\"authors\":\"Valentina O Puntmann, Dietrich Beitzke, Andreas Kammerlander, Inga Voges, Dominik D Gabbert, Marcus Doerr, Bishwas Chamling, Biykem Bozkurt, Juan Carlos Kaski, Erica Spatz, Eva Herrmann, Gernot Rohde, Philipp DeLeuw, Lenka Taylor, Christine Windemuth-Kieselbach, Cornelia Harz, Marta Santiuste, Laura Schoeckel, Juliana Hirayama, Peter C Taylor, Colin Berry, Eike Nagel\",\"doi\":\"10.1016/j.jocmr.2024.101121\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cardiac symptoms due to postacute inflammatory cardiac involvement affect a broad segment of previously well people with only mild acute COVID-19 illness and without overt structural heart disease. Cardiac magnetic resonance (CMR) imaging can identify the underlying subclinical disease process, which is associated with chronic cardiac symptoms. Specific therapy directed at reducing postacute cardiac inflammatory involvement prior to development of myocardial injury and impairment is missing.</p><p><strong>Trial design: </strong>Prospective multicentre randomised placebo-controlled study of myocardial protection therapy (combined immunosuppressive/antiremodelling) of low-dose prednisolone and losartan. Consecutive symptomatic individuals with a prior COVID-19 infection, no preexisting significant comorbidities or structural heart disease, undergo standardised assessments with questionnaires, CMR imaging and cardiopulmonary exercise testing (CPET). Eligible participants fulfilling the criteria of subclinical Post-COVID inflammatory involvement on baseline CMR examination are randomised to treatment with either verum or placebo for a total of 16 weeks (W16). Participants and investigators remain blinded to the group allocation throughout the study duration. The primary efficacy endpoint is the absolute change of left ventricular ejection fraction (LVEF) to baseline at W16, measured by CMR, between the verum treatment and placebo group by absolute difference, using unpaired t-test confirmatively at the 5% significance level. Secondary endpoints include assessment of changes of symptoms, CMR parameters, and CPET after W16, and frequency of major adverse cardiac events after 1 year. Safety data will be analysed for frequency, severity and types of adverse events (AEs) for all treatment groups. The proportion of AEs related to the contrast agent gadobutrol will also be analysed. A calculated sample size is a total of 280 participants (accounting for 8% drop-out), randomised in 1:1 fashion to 140 in the verum and 140 placebo group.</p><p><strong>Conclusion: </strong>Myoflame-19 study will examine the efficacy of a myocardial protection therapy in symptomatic participants with post-COVID inflammatory cardiac involvement determined by CMR. The aim of the intervention is to reduce the symptoms and inflammatory myocardial injury, to improve exercise tolerance and preclude the development of cardiac impairment.</p><p><strong>Clinical trial identifier: </strong>NCT05619653.</p>\",\"PeriodicalId\":15221,\"journal\":{\"name\":\"Journal of Cardiovascular Magnetic Resonance\",\"volume\":\" \",\"pages\":\"101121\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2024-10-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiovascular Magnetic Resonance\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.jocmr.2024.101121\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular Magnetic Resonance","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jocmr.2024.101121","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0

摘要

背景:急性炎症后心脏受累引起的心脏症状影响着许多以前健康的人,他们只有轻微的急性 COVID-19 疾病,没有明显的结构性心脏病。心脏磁共振(CMR)成像可确定与慢性心脏症状相关的潜在亚临床疾病过程。目前还缺乏在心肌损伤和功能障碍发生之前减少急性期后心脏炎症受累的具体疗法:试验设计:对小剂量泼尼松龙和洛沙坦的心肌保护疗法(联合免疫抑制/抗炎症)进行前瞻性多中心随机安慰剂对照研究。对既往感染过 COVID-19、无重大并发症或结构性心脏病的连续无症状患者进行标准化评估,包括问卷调查、CMR 成像和心肺运动测试 (CPET)。在基线 CMR 检查中符合亚临床后 COVID 炎症受累标准的合格参与者将被随机分配接受维鲁姆或安慰剂治疗,共 16 周(W16)。在整个研究期间,参与者和研究人员对组别分配保持盲法。主要疗效终点是维鲁姆治疗组和安慰剂组在W16时通过CMR测量的左心室射血分数(LVEF)与基线值的绝对差异,采用非配对t检验,显著性水平为5%。次要终点包括评估 W16 后症状、CMR 参数和 CPET 的变化,以及 1 年后重大心脏不良事件的发生频率。安全性数据将分析所有治疗组不良事件(AEs)的频率、严重程度和类型。还将分析与造影剂钆布醇有关的不良事件比例。计算得出的样本量为 280 名参与者(考虑到 8% 的退选率),以 1:1 的方式随机分为 140 名 verum 组和 140 名安慰剂组:Myoflame-19研究将检验心肌保护疗法对CMR确定的COVID后炎症性心脏受累的无症状参与者的疗效。干预的目的是减轻症状和炎症性心肌损伤,提高运动耐量,防止心功能损害的发生:临床试验标识符:NCT05619653。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Design and Rationale of MYOFLAME-19 RCT: MYOcardial protection to reduce inFLAMmatory heart disease due to COVID-19 Infection using CMR Endpoints.

Background: Cardiac symptoms due to postacute inflammatory cardiac involvement affect a broad segment of previously well people with only mild acute COVID-19 illness and without overt structural heart disease. Cardiac magnetic resonance (CMR) imaging can identify the underlying subclinical disease process, which is associated with chronic cardiac symptoms. Specific therapy directed at reducing postacute cardiac inflammatory involvement prior to development of myocardial injury and impairment is missing.

Trial design: Prospective multicentre randomised placebo-controlled study of myocardial protection therapy (combined immunosuppressive/antiremodelling) of low-dose prednisolone and losartan. Consecutive symptomatic individuals with a prior COVID-19 infection, no preexisting significant comorbidities or structural heart disease, undergo standardised assessments with questionnaires, CMR imaging and cardiopulmonary exercise testing (CPET). Eligible participants fulfilling the criteria of subclinical Post-COVID inflammatory involvement on baseline CMR examination are randomised to treatment with either verum or placebo for a total of 16 weeks (W16). Participants and investigators remain blinded to the group allocation throughout the study duration. The primary efficacy endpoint is the absolute change of left ventricular ejection fraction (LVEF) to baseline at W16, measured by CMR, between the verum treatment and placebo group by absolute difference, using unpaired t-test confirmatively at the 5% significance level. Secondary endpoints include assessment of changes of symptoms, CMR parameters, and CPET after W16, and frequency of major adverse cardiac events after 1 year. Safety data will be analysed for frequency, severity and types of adverse events (AEs) for all treatment groups. The proportion of AEs related to the contrast agent gadobutrol will also be analysed. A calculated sample size is a total of 280 participants (accounting for 8% drop-out), randomised in 1:1 fashion to 140 in the verum and 140 placebo group.

Conclusion: Myoflame-19 study will examine the efficacy of a myocardial protection therapy in symptomatic participants with post-COVID inflammatory cardiac involvement determined by CMR. The aim of the intervention is to reduce the symptoms and inflammatory myocardial injury, to improve exercise tolerance and preclude the development of cardiac impairment.

Clinical trial identifier: NCT05619653.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
10.90
自引率
12.50%
发文量
61
审稿时长
6-12 weeks
期刊介绍: Journal of Cardiovascular Magnetic Resonance (JCMR) publishes high-quality articles on all aspects of basic, translational and clinical research on the design, development, manufacture, and evaluation of cardiovascular magnetic resonance (CMR) methods applied to the cardiovascular system. Topical areas include, but are not limited to: New applications of magnetic resonance to improve the diagnostic strategies, risk stratification, characterization and management of diseases affecting the cardiovascular system. New methods to enhance or accelerate image acquisition and data analysis. Results of multicenter, or larger single-center studies that provide insight into the utility of CMR. Basic biological perceptions derived by CMR methods.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信