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: 2013年1月21日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Pharma Nord ApS