EUCTR2022-001682-12-AT招募中1 期
Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in patients with postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19) - MYOFLAME-19
Goethe University Frankfurt0 个研究点目标入组 280 人开始时间: 2022年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants = 18 years
- •Participants with documented recent COVID19 infection (> 4 weeks)
- •Post-acute sequelae of SARS-CoV-2 infection (PASC) Syndrome, defined by persistence or new symptoms, not present prior to the infection.
- •Cardiovascular magnetic resonance imaging (CMR) evidence of inflammatory cardiac involvement at baseline (BL) by any of the following criteria:
- •o Increased native T1= 1130 ms at 3.0 Tesla (or 1030 ms at 1.5 Tesla) and/or;
- •o Increased native T2 =39.5 ms at 3.0 Tesla (or 49.5 at 1.5 Tesla) and/or
- •o present non-ischaemic myopericardial Late gadolinium enhancement (LGE) and/or;
- •o Left ventricular ejection fraction (LVEF) =45 - =50%.
- •Willingness to comply with the study procedures and study protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •Severe course of acute COVID illness requiring hospitalisation
- •Known allergy to or intolerance of the study medications
- •Symptomatic hypotension (systolic blood pressure less than 90 mm Hg), not reversible with oral hydration
- •Any previous or current use of ACE inhibitors, AR Blockers
- •Any previous oral prednisolone, or any other immunosuppressive or biological treatment (within 10 weeks)
- •History or CMR evidence of preexisting heart disease, including:
- •a. Known cardiac impairment with LVEF =44%
- •b. Congestive heart failure (NYHA III-IV)
- •c. Active heart failure treatment
- •d. Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
- •e. Persistent or permanent atrial fibrillation or significant heart rhythm abnormalities.
- •f. Congenital or clinically relevant valvular heart disease (moderate or severe)
- •g. Specific cardiomyopathy (hypertrophic, hypertensive heart disease, amyloidosis, previous myocarditis, non-ischaemic dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, non-compaction cardiomyopathy, etc).
- •h. Known significant concomitant diseases that are likely to interfere with the evaluation of the participant's safety and of the study outcome (e.g. diabetes, lung or hepatic disease, epilepsy, psychiatric disorders, renal disease with a current estimated GFR <30 mL/min/1.73 m² using MDRD formula, chronic systemic infection or immunocompromise)
- •i. Exceeding scanner bore and table-holding capacity: Weight >125 kg, BMI > 35 kg/m2
- •Contraindications to contrast-enhanced CMR imaging, e.g.
- •a. MR-unsafe implantable device
- •b. known allergy to gadolinium-based contrast agent (GBCA)
- •For female participants:
- •a. Pregnant or lactating women
- •b. Women of childbearing potential not willing to use effective contraception (as defined in18.2.13)
- •Known alcohol, drug, or chemical abuse
- •Participants currently participating in an investigational study or for whom participation is planned.
- •Unable to provide written informed consent
- •Patients with CMR evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigations.
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