EUCTR2017-002049-31-DK进行中（未招募）1 期
Effect of Levosimedan or Placebo on Exercise Capatity and hemodynamics in Patients with Advanced Chronic Heart Failure (LOCO-CHF trial) - LOCO-CHF trial
Heart Center, Department of Cardiology, Rigshospitalet0 个研究点目标入组 42 人开始时间: 2017年7月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •Age =18 years
- •NYHA III-IV on optimal medical treatment
- •LVEF =35%
- •NT-proBNP >600 µg/L
- •pVO2 <20 ml/kg/min
- •No hospitalization for HF or change in loop diuretic <2 weeks
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Recent or acute coronary and respiratory syndromes
- •Recent sustained ventricular tachycardia or ventricular fibrillation
- •Severe aortic or mitral valve disease
- •Known malfunctioning artificial heart valve
- •Uncorrected obstructive valvular disease
- •Hypertrophic cardiomyopathy
- •Fertile women
- •Uncorrected thyroid disease
- •Presence of any disease/condition that might per se influence exercise performance
- •Left ventricular assist device
- •Pacemaker-guided heart rate at rest or during exercise
- •Known contraindication for treatment with levosimendan
- •Any treatment with levosimendan in the previous 6 months
- •Inability to perform a VO2max test
- •Symptomatic hypotension or systolic blood pressure < 90 mmHg
研究者
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