Study summary: Q-Symbio trial, a multicentre trial conducted in National Heart Centre, Malaysia.
Copyright © 2011 - 2013 Sun Pharmaceutical Sdn Bhd. All Rights Reserved.
Follow us
Q10 as adjunctive treatment of Chronic Heart Failure.A Randomized, double-blind, multicenter-trial with focus on Symptoms, BIomarker status (BNP), and long-term Outcome (hospitalisations/mortality. (Q-SYMBIO)
Bio-Quinone Q10 100mg (Coenzyme Q10 100mg)
Symptomatic relief and reduced hospitalisation/mortality in chronic heart failure.
Randomised, placebo controlled, parallel, multicenter study.
550 Patients diagnosed with chronic heart failure, preferably in NYHA class III or IV. In stable medical treatment of heart failure within the last 3 months.
17 (Worldwide)
Dato Dr Chew Soon Ping & Dato Dr Aizai Azlan, National Heart Centre, Malaysia.
Bio-Quinone Q10 100mg t.i.d or similar placebo
106 weeks
Title:
Study drug:
Intended indication:
Study design:
Patient Population:
Number of Centres:
Investigators:
Treatment Groups:
Duration of dosing:
Efficacy Parameters:
Primary:
Physicians assessment(short-term):
- New York Heart Association (NYHA) classification.
- 6 minutes hall walk distance (6MW).
Levels of N terminal pro BNP at entry and at the termination of the trial (short-term).
Major adverse cardiovascular events (MACE)(long-term):
- Unplanned hospitalisations (HF), death, urgent transplant, mechanical assist
Secondary:
Patients assessment (short-term):
- Dyspnea and fatigue (visual analogue scale).
- Evaluation of change in symptoms (VAS).
NYHA symptom class (long-term)
Serum BNP(long-term)
Echocardiography(long-term)
Other parameters:
- Heart rate.
- Blood pressure.
- Serum Q10 at entry and at the termination of the trial period.
- A list of medications, and any change of medications during the study.
- Echocardiographic parameters (LVEDD, LVESD, LVEF, RV, LA, E/A-ratio)
- Other hospitalisations or trauma.
- Side effects and safety.
- Compliance.
Safety Parameters: Adverse events.
