ISRCTN94506234已完成不适用
Coenzyme Q10 as adjunctive treatment of chronic heart failure: a randomised, double-blind, multicentre trial with focus on SYMptoms, BIOmarker status (Brain-Natriuretic Peptide [BNP]), and long-term outcome (hospitalisations/mortality)
Pharma Nord ApS (Denmark)0 个研究点目标入组 550 人开始时间: 2007年4月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
入排标准
入选标准
- •1. Patients above the age of 18 years with chronic heart failure
- •2. New York Heart Association (NYHA) class III or IV with ability to participate in a six-minutes walk test
- •3. Stable on maximum current heart failure therapy
- •4. Informed consent obtained
排除标准
- •1. Myocardial infarction, unstable angina, percutaneous coronary intervention or cardiac surgery within the past six weeks
- •2. Heart failure due to congenital heart disease
- •3. Uncorrected valvular heart disease, planned valve surgery
- •4. Urgent waiting-list for heart transplantation (status-one patients)
- •5. Restrictive (including amyloid) cardiomyopathy
- •6. Alcoholic heart disease
- •7. Acute myocarditis
- •8. Patients on continuous intravenous (i.v.) therapy for heart failure
- •9. Patients with mechanical assist device
- •10. Stroke within the past six weeks
- •11. Women of childbearing potential and lactating females
- •12. Supplementary CoQ10 intake within the last month before run-in
- •13. Six-minutes walk distance greater than 450 metres
- •14. Life expectancy less than one year due to non-cardiac causes
- •15. Psychosocial instability or anticipated problems with compliance
- •16. Participation in another controlled trial
- •17. Lack of informed consent
- •18. Allergic to the constituents of the test medication (ubidecarenone, soy oil, alpha-tocopherol, gelatine)
- •19. Other serious disease including tumourous disease
- •20. Participation in other clinical trials
研究者
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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-SYMBIOChronic heart failure for more than 6 weeks, in NYHA class III or IV. Age>18 yearsmales and females. Optimal medical treatment of heart failure according to the investigators opinion.EUCTR2005-002960-27-HUPharma Nord ApS550
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