Condition category
Circulatory System
Date applied
23/03/2007
Date assigned
23/04/2007
Last edited
06/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Christian Sindberg

ORCID ID

Contact details

Pharma Nord ApS
Sadelmagervej 30-32
Vejle
7100
Denmark
+45 75857400
cdsindberg@pharmanord.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P-6708

Study information

Scientific title

Acronym

Q-SYMBIO

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Coenzyme Q10

Primary outcome measures

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 measures

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)

Overall trial start date

01/04/2003

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

550

Participant 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

Recruitment start date

01/04/2003

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Australia, Austria, Denmark, Hungary, India, Malaysia, Poland, Slovakia, Sweden

Trial participating centre

Pharma Nord ApS
Vejle
7100
Denmark

Sponsor information

Organisation

Pharma Nord ApS (Denmark)

Sponsor details

Sadelmagervej 30-32
Vejle
7100
Denmark

Sponsor type

Industry

Website

http://www.pharmanord.dk/wstore/contentServlet

Funders

Funder type

Industry

Funder name

Pharma Nord ApS (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

International Coenzyme Q10 Association (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kaneka Corporation of Osaka (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25282031

Publication citations

  1. Results

    Mortensen SA, Rosenfeldt F, Kumar A, Dolliner P, Filipiak KJ, Pella D, Alehagen U, Steurer G, Littarru GP, , The Effect of Coenzyme Q10 on Morbidity and Mortality in Chronic Heart Failure: Results From Q-SYMBIO: A Randomized Double-Blind Trial., JACC Heart Fail, 2014, doi: 10.1016/j.jchf.2014.06.008.

Additional files

Editorial Notes