E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |