EUCTR2007-002893-76-CZ进行中(未招募)不适用
MEtabolic Therapy with Trimetazidine in Acute heart failure: an open pilot randomized trial (The METTA – PRAGUE 10 Trial) - METTA - PRAGUE 10
Charles University in Prague, Third Faculty of Medicine0 个研究点目标入组 100 人开始时间: 2007年7月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
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
- •1.Dyspnea at rest due to acute heart failure (defined as a presence of at least one of the following: S3 gallop OR pulmonary rales OR X-ray prove of pulmonary congestions OR PCW pressure > 25 mmHg).
- •2.Decreased oxygen saturation (value obtained from pulse oxymetry) within one hour of admission to ICU.
- •3.Signed informed consent
- •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
- •1.Age less than 18 years.
- •2.Acute persistent ST-elevation on ECG at admission.
- •3.Progressive shock (defined as spontaneous systolic blood pressure < 90 mmHg OR systolic blood pressure < 100 mmHg despite dopamin or dobutamin therapy up to 8 µg/kg/min OR any hypotension requiring noradrenalin or adrenalin administration).
- •4.Patient already on metabolic-modulation therapy.
- •5.History of allergy to trimetazidine or any additives present in the drug.
- •6.Inability to ingest oral medication.
- •7.Unwillingness to be followed for the duration of the study.
- •8.Women of childbearing potential who are pregnant, nursing or not using effective contraception.
- •9.Disability of oral drug intake.
研究者
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