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

• Conditions: Chronic heart failure for more than 6 weeks, in NYHA class III or IV. Age>18 years; males and females. Optimal medical treatment of heart failure according to the investigators opinion.

• Registration Number: EUCTR2005-002960-27-HU
• Lead Sponsor: Pharma Nord ApS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-20
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified