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| 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) |
| ISRCTN | ISRCTN94506234 |
| ClinicalTrials.gov identifier | |
| Public title | 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) |
| Scientific title | |
| Acronym | Q-SYMBIO |
| Serial number at source | P-6708 |
| Study hypothesis | Adjuvant treatment of heart failure patients with coenzyme Q10 versus placebo will improve the patients symptoms and functional status and affect positively morbidity (unplanned cardiovascular hospitalisations) and mortality as a composite endpoint. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Approval received from the The Ethical Scientific Committees for Copenhagen and Frederiksberg Municipality on the June 27th 2003 (ref: (KF) 02-023/03).
The trial will respect the Helsinki (II) declaration, and have been evaluated and accepted by the relevant ethics committee(s). Written consent is obtained from each patient and the anonymity of each patient will be respected and ensured. |
| Study design | Randomised, placebo controlled, parallel, multicentre study |
| Countries of recruitment | Australia, Austria, Denmark, Hungary, India, Malaysia, Poland, Slovakia, Sweden |
| Disease/condition/study domain | Established chronic heart failure due to predominantly ishaemic heart disease or cardiomyopathy. |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 01/10/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 550 |
| Interventions | Capsules containing 300 mg of CoQ10 daily or similar placebo capsules containing soy oil. |
| Primary outcome measure(s) |
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 outcome measure(s) |
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) |
| Sources of funding |
1. Pharma Nord ApS (Denmark)
2. International Coenzyme Q10 Association (Italy) 3. Kaneka Corporation of Osaka (Japan) |
| Trial website | |
| Publications | |
| Contact name | Mr Christian Sindberg |
| Address |
Pharma Nord ApS
Sadelmagervej 30-32 |
| City/town | Vejle |
| Zip/Postcode | 7100 |
| Country | Denmark |
| Tel | +45 75857400 |
| Fax | +45 75858540 |
| cdsindberg@pharmanord.com | |
| Sponsor | Pharma Nord ApS (Denmark) |
| Address | Sadelmagervej 30-32 |
| City/town | Vejle |
| Zip/Postcode | 7100 |
| Country | Denmark |
| Sponsor website: | http://www.pharmanord.dk/wstore/contentServlet |
| Date applied | 23/03/2007 |
| Last edited | 11/08/2011 |
| Date ISRCTN assigned | 23/04/2007 |
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