2024-516463-84-00招募中3 期
Randomised placebo controlled clinical trial of efficacy of MYOcardial protection in postacute inFLAMmatory cardiac involvEment due to COVID-19 (MYOFLAME-19)
Goethe University Frankfurt3 个研究点 分布在 2 个国家目标入组 280 人开始时间: 2024年10月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 3
- 主要终点
- The primary endpoint of this study is absolute LVEF change to baseline at W16, measured by CMR, compared between the verum and placebo group by absolute treatment difference
研究概览
简要总结
The primary objective is to determine the efficacy of a combined immunosuppressive and antiremodelling therapy in COVID-19 related inflammatory cardiovascular involvement by CMR to reduce inflammatory myocardial injury compared to placebo. The primary safety objective is to demonstrate that a combined immunosuppressive and antiremodelling therapy in proposed doses in this patient population is safe.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
排除标准
- •Severe course of acute COVID illness requiring hospitalisation
- •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 (CBGA)
- •For female participants: a. Pregnant or breastfeeding women b. Women of childbearing potential not willing to use highly effective contraception (as defined in 18.2.13)
- •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.
- •Participants with CMR evidence of structural heart disease or incidental heart rhythm abnormalities will be advised to see their own doctor for further investigation.
- •Participants currently participating in an investigational study or for whom participation is planned.
- •Unable to provide written informed consent
- •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 prior 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, noncompaction cardiomyopathy, etc).
- •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)
结局指标
主要结局
The primary endpoint of this study is absolute LVEF change to baseline at W16, measured by CMR, compared between the verum and placebo group by absolute treatment difference
The primary endpoint of this study is absolute LVEF change to baseline at W16, measured by CMR, compared between the verum and placebo group by absolute treatment difference
次要结局
- The secondary endpoints include the following continuous endpoints, where "changes" refer to the difference between baseline and W16 (BL, absolute and in %):
- Mean Late gadolinium enhancement (LGE) extent (%) and change thereof compared to BL
- CPET (achieved Work Rate, VO2max, VCO2 max, RER, AT, slope) and change thereof compared to BL
- Mean T1 and T2 values (ms) and change thereof compared to BL
- Mean LV and RV volumes (ml/m2) and LV mass (g/m2) as well as derived parameters and change thereof compared to BL
- Mean Myocardial strain (%) and change thereof compared to BL
- Mean Pulse wave velocity (m/s) and change thereof compared to BL
- Aortic wall thickness (LGE, mm); and change thereof compared to BL
- Average Symptom Score and change thereof compared to BL
- Compliance: Frequency of prescribed medication consumed, participants diary and drug adherence, total cumulative steroid dose;
- Tolerance: number of participants who required dose reduction or treatment cessation due to side effects, especially due to o Hypotension o Unblinding due to emergency safety issues
- Number of Responders by achieving: o partial response: a normal CMR result is defined as normal T1 and T2, normal gender-age predicted LVEF, non-dilated LV o total response: in addition to the above absence of LGE
- Proportion of participants with HF or MACE after 1 year
- 1 year Event-free survival
研究者
Dr. Valentina Puntmann
Scientific
Goethe University Frankfurt
研究点 (3)
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