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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
DOI 10.1186/ISRCTN94506234
ClinicalTrials.gov identifier
EudraCT number
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 The Ethical Scientific Committees for Copenhagen and Frederiksberg Municipality, 27/06/2003, 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 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282031
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
  Email 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 06/10/2014
Date ISRCTN assigned 23/04/2007
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