EUCTR2005-002960-27-HU进行中（未招募）不适用
Coenzyme Q10 as adjunctive treatment of chronic heart failure. A randomised double-blind multicenter trial with focus on Symptoms, Biomarker status (BNP) and long-term Outcome (hospitalisation/mortality).(Q-Symbio). - Q-SYMBIO
Pharma Nord ApS0 个研究点目标入组 550 人开始时间: 2006年1月20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
- 550
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 aged 18 years and up with chronic heart failure, in NYHA class III or IV with ability to participate in a 6-minutes walk test. Stable on maximum current heart failure therapy.
- •Informed consent obtained.
- •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
- •Myocardial infarction, unstable angina, percutaneous coronary intervention or cardiac surgery within the past 6 weeks.
- •Heart failure due to congenital heart disease.
- •Uncorrected valvular heart disease, planned valve surgery
- •Urgent waiting-list for heart transplantation (status-1 patients)
- •Restrictive (incl. amyloid) cardiomyopathy
- •Alcoholic heart disease
- •Acute myocarditis.
- •Patients on continuous i.v. therapy for heart failure
- •Patients with mechanical assist device.
- •Stroke within the past 6 weeks
- •Women of childbearing potential and lactating females.
- •Supplementary CoQ10 intake within the last month before run-in.
- •6-minutes walk distance > 450 meters
- •Life expectancy < 1 year due to non-cardiac causes
- •Psychosocial instability or anticipated problems with compliance
- •Participation in another controlled trial
- •Lack of informed consent
- •Allergic to the constituents of the test medication (ubidecarenone, soy oil, alpha-tocopherol, gelatine).
- •Other serious disease including tumourous disease.
- •Participation in other clinical trials.
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