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)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 550

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Major Adverse Cardiovascular Events (MACE) defined as:<br>a. unplanned hospitalisations due to worsening heart failure<br>b. cardiovascular death<br>c. urgent cardiac transplantation, or<br>d. mechanical support<br>Using a time to first event analysis (composite endpoint)<br>2. Physicians assessment:<br>a. New York Heart Association (NYHA) classification<br>b. Six Minutes hall Walk distance (6MW)

Secondary Outcome Measures

Name	Time	Method
1. NYHA symptom class, serum pro-BNP, echocardiography<br>2. Patients assessment:<br>a. dyspnea and fatigue (Visual Analogue Scale [VAS])<br>b. evaluation of change in symptoms (VAS)