Established chronic heart failure due to predominantly ishaemic heart disease or cardiomyopathy. Circulatory System Chronic heart failure
Conditions
Interventions
Capsules containing 300 mg of CoQ10 daily or similar placebo capsules containing soy oil.
Sponsors
Pharma Nord ApS (Denmark)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Cardiovascular Events (MACE) defined as: a. unplanned hospitalisations due to worsening heart failure b. cardiovascular death c. urgent cardiac transplantation, or d. mechanical support Using a time to first event analysis (composite endpoint) 2. Physicians assessment: a. New York Heart Association (NYHA) classification b. Six Minutes hall Walk distance (6MW) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NYHA symptom class, serum pro-BNP, echocardiography 2. Patients assessment: a. dyspnea and fatigue (Visual Analogue Scale [VAS]) b. evaluation of change in symptoms (VAS) | — |
Countries
Australia, Austria, Denmark, Hungary, India, Malaysia, Poland, Slovakia, Sweden
Outcome results
None listed