EUCTR2020-005600-19-FR进行中（未招募）1 期
EvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction - LEONARD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation [effective regurgitant orifice (ERO)>20mm², or systolic hepatic vein flow blunting or reversal]
- •-Written signed informed consent
- •-Affiliation to the French health care system (Sécurité Sociale)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Age < 18 years
- •-Severe organic renal dysfunction defined by creatinine clearance <30mL/min
- •-Recent endocarditis (<3 months)
- •-Recent myocardial infarction (<3 months)
- •-Tricuspid valve perforation or prolapse
- •-Cardiogenic shock requiring dobutamine support or cardiac assistance
- •-Severe liver injury (CHILD C)
- •-Left ventricular obstruction
- •-Allergy to levosimedan
- •-Current participation in other investigational drug or device studies or being in the exclusion period at the end of a previous study involving human participants, if applicable
- •-Pregnant or breastfeeding women
- •-Females of childbearing potential without effective method of birth control
- •-Patient on AME (state medical aid) unless exemption from affiliation
- •-Hypotension with SBP<90mmHg
- •-Severe tachycardia
- •-History of torsade de pointe
研究者
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