2023-506599-28-01招募中2 期
Pulse corticosteroids or/and Immunoglobulins to treat fulminant Myocarditis: a double-blind randomized controlled adaptive trial (The CORIUM study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- - A hierarchical composite outcome assessed at day 28 of mortality or heart transplantation/VAD/persisting t-MCS and the number of days alive without t-MCS and inotropes within the 28 days following randomization
研究概览
简要总结
To assess at day 28 the efficacy of pulse bolus corticosteroids or pulse bolus corticosteroids and IVIG vs double placebo on a composite hierarchical outcome of mortality or heart transplantation/ long-term ventricular assist device (VAD)/persisting t-MCS and the number of days alive between randomization and day 28 without t-MCS and inotropes.
研究设计
- 分配方式
- Randomized
- 主要目的
- The CORIUM study
- 盲法
- Double (Subject, Carer, Investigator)
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
- •Fulminant myocarditis defined by • the acute illness (<1 month from symptom onset), • hemodynamic compromise due to cardiogenic shock or electrical storm, • elevated plasma cardiac troponin > twice normal value • need for hemodynamic support (inotropes or temporary mechanical circulatory support) for less than 72 hours in the absence of an ischemic cause or other pre-existing cardiomyopathies Noticeably, a coronary angiogram should be performed in patients ≥40 years of age when myocarditis has not been proven histologically. Besides, an endomyocardial biopsy will not be mandatory to fulfill the definition of fulminant myocarditis.
- •Signed informed consent from the patient, a close relative or surrogate or a family member or a legal representative for minor patient. • Adult : According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patientis unable to give his/her consent and when the close relative/surrogate/family member are absent. Close relative/surrogate/family member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow. • Minor : According to the specifications of emergency inclusion, randomization could be performed when legal representative are absent. Legal representative consent will be asked as soon as possible after randomization
- •Social security registration (AME excluded)
排除标准
- •Patient moribund on the day of randomization, SAPS II >90
- •Contraindication or allergies to corticosteroids or immunoglobulins or any components of the formulations or their excipients
- •Patients already on corticosteroids or receiving IVIG
- •Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •Pregnancy or breastfeeding or baby delivery <6 months
- •Initiation of inotropes or temporary mechanical circulatory support >72 hours
- •Resuscitation >20 minutes (cumulative low-flow time > 20 minutes )
- •Pre-existing ischemic or dilated cardiomyopathy
- •Known systemic autoimmune disorder or other conditions requiring immunosuppression
- •Patients with peripheral eosinophilia (≥1000 G/L)
- •Myocarditis associated with anti-cancer immune checkpoint inhibitor agents
- •Active severe bacterial or fungal infectious disease
结局指标
主要结局
- A hierarchical composite outcome assessed at day 28 of mortality or heart transplantation/VAD/persisting t-MCS and the number of days alive without t-MCS and inotropes within the 28 days following randomization
- A hierarchical composite outcome assessed at day 28 of mortality or heart transplantation/VAD/persisting t-MCS and the number of days alive without t-MCS and inotropes within the 28 days following randomization
次要结局
- Mortality at day 28/60/90
- - VAD or/and heart transplant at day 28/60/90
- - Number of t-MCS-free days at day 28
- - Number of inotropes-free days at day 28
- - Time to improvement in left ventricular function assessed by echocardiography at D3/D7/D14/D28 following randomization
- - Time to normalize troponin and N-terminal pro–B-type natriuretic peptide within 14 days after randomization
- - Incidence of drugs side effects (nosocomial infections, significant gastrointestinal bleeding, renal insufficiency, acute delirium leading to the use of neuroleptic agents)
- - Proportion of patients with left ventricular ejection fraction (LVEF) < 55% and/or left ventricular dilatation at 28-day
- - Proportion of patients with at least one episode of ventricular arrhythmia at day-28
- - Proportion of patients with at least one episode of atrioventricular block (degree II and III) or sinoatrial, atrioventricular or intraventricular block
- - The proportion of patients with LVEF<55%, left ventricular dilatation, and late gadolinium enhancement at 6 months evaluated by cardiac magnetic resonance imaging
研究者
Coordinating Investigator
Scientific
Assistance Publique Hopitaux De Paris
研究点 (4)
Loading locations...
相似试验
招募中
3 期
Low dose corticosteroids adjacent to enzyme replacement therapy or chaperon therapy in patients with cardiac manifestation of Fabry diseaseFabry disease2025-521408-24-00Medical University Of Lodz40
招募中
3 期
Hydrocorticose and vasopressin in post-resuscitation syndrome2024-516373-77-00Assistance Publique Hopitaux De Paris380
招募中
4 期
Evaluation of efficacy and tolerance of fludrocortisone (Flucortac) in the treatment of neurogenic orthostatic hypotension2024-517841-16-00H.A.C. Pharma90
招募中
3 期
Hydrocortisone and Fludrocortisone for Critical Illness-related Corticosteroid Insufficiency2024-516021-32-00Assistance Publique Hopitaux De Paris3,276
招募中
3 期
Repeated corticosteroid injections around the Greater Occipital Nerve (GON) as prophylactic treatment in chronic cluster headacheCluster headache2024-514311-10-00Leids Universitair Medisch Centrum (LUMC)50