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	https://doi.org/10.1186/ISRCTN94506234
Protocol serial number	P-6708
Sponsor	Pharma Nord ApS (Denmark)
Funders	Pharma Nord ApS (Denmark), International Coenzyme Q10 Association (Italy), Kaneka Corporation of Osaka (Japan)

Submission date: 23/03/2007
Registration date: 23/04/2007
Last edited: 06/10/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Christian Sindberg
Scientific

Pharma Nord ApS
Sadelmagervej 30-32
Vejle
7100
Denmark

Phone	+45 75857400
Email	cdsindberg@pharmanord.com

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled parallel multicentre study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Q-SYMBIO
Study objectives	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.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	Established chronic heart failure due to predominantly ishaemic heart disease or cardiomyopathy.
Intervention	Capsules containing 300 mg of CoQ10 daily or similar placebo capsules containing soy oil.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Coenzyme Q10
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)
Key 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)
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	550
Key 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
Key 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
Date of first enrolment	01/04/2003
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Australia
Austria
Denmark
Hungary
India
Malaysia
Poland
Slovakia
Sweden

Study participating centre

Pharma Nord ApS

Vejle
7100
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No