Chronic heart failure for more than 6 weeks, in NYHA class III or IV. Age>18 years
Conditions
Interventions
Trade Name: Myoqinon 100 mg soft gelatine capsule
Product Name: Myoqinon 100 mg soft gelatine capsule
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: UBIDECARENONE
CAS Number: 303980
Concentra
Sponsors
Pharma Nord ApS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is a two-phase objective of the trial. The aim of the first part of the study is a short-term evaluation of the patients symptoms and functional status (including a 6 minutes walk test) during treatment with CoQ10 and to monitor basic physiological parameters such as heart rate and blood pressure. The aim of the second part of the study is a long-term follow up to evaluate the effects on morbidity (unplanned cardiovascular hospitalisations) and mortality as a composite endpoint in patients with severe heart failure receiving optimal medical therapy. ;Secondary Objective: Serum samples for determination of N terminal pro brain natriuretic peptide (NT pro BNP) will be obtained at entry in the study and at follow-up to evaluate the hypothesis that CoQ10 may reduce the level of natriuretic peptides.;Primary end point(s): Physicians assessment a)New York Heart Association (NYHA) classification b)6 minutes hall walk distance (6MW) Levels of N terminal pro BNP at entry and after 16 weeks Major adverse cardiovascular events | — |
Countries
Hungary
Outcome results
None listed