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Randomized Controlled Trial
. 2011 Apr;34(4):211-7.
doi: 10.1002/clc.20846.

Coenzyme Q10 terclatrate and creatine in chronic heart failure: a randomized, placebo-controlled, double-blind study

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Randomized Controlled Trial

Coenzyme Q10 terclatrate and creatine in chronic heart failure: a randomized, placebo-controlled, double-blind study

Stefano Fumagalli et al. Clin Cardiol. 2011 Apr.

Abstract

Background: Studies have suggested that micronutrient deficiency has some role in the progression of chronic heart failure (CHF).

Hypothesis: Oral supplementation with coenzyme Q(10) (CoQ(10)) and creatine may reduce mitochondrial dysfunction that contributes to impaired physical performance in CHF.

Methods: We conducted a randomized, double-blind, placebo-controlled trial to determine the effect of a mixture of water-soluble CoQ(10) (CoQ(10) terclatrate; Q-ter) and creatine on exercise tolerance and health-related quality of life. Exercise tolerance was measured as total work capacity (kg·m) and peak oxygen consumption (VO(2), mL/min/kg), both from a cardiopulmonary exercise test. Health-related quality of life was measured by the Sickness Impact Profile (SIP) in CHF secondary to left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 35%). After baseline assessment, 67 patients with stable CHF were randomized to receive Q-ter 320 mg + creatine 340 mg (n = 35) or placebo (n = 32) once daily for 8 weeks.

Results: At multivariate analysis, 8-week peak VO(2) was significantly higher in the active treatment group than in the placebo group (+1.8 ± 0.9 mL/min/kg, 95% CI: 0.1-3.6, P < 0.05). No untoward effects occurred in either group.

Conclusions: This study suggests that oral Q-ter and creatine, added to conventional drug therapy, exert some beneficial effect on physical performance in stable systolic CHF. Results may support the design of larger studies aimed at assessing the long-term effects of this treatment on functional status and harder outcomes.

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Figures

Figure 1
Figure 1
Univariate analysis of changes in TWC (A) after 8 weeks of oral supplementation of Q‐ter + creatine (black boxes) or placebo (open boxes). Change from baseline was significant only with active treatment. (B) Multivariate analysis of mean difference (±SE) in TWC at 8 weeks between treatment groups (Q‐ter + creatine vs placebo), adjusted for diabetes. Dashed lines represent the 95% confidence intervals of the estimate. Lower standard error bar across the 0 line indicates no difference in TWC between the 2 groups. Abbreviations: Q‐ter, coenzyme Q10 terclatrate; TWC, total work capacity.
Figure 2
Figure 2
Univariate analysis of changes in peak VO2 (A) after 8 weeks of oral supplementation of Q‐ter + creatine (black boxes) or placebo (open boxes). Change from baseline was significant only with active treatment. (B) Multivariate analysis of mean difference (±SE) in peak VO2 at 8 weeks between treatment groups (Q‐ter + creatine vs placebo), adjusted for peripheral artery disease (see text). Dashed lines represent the 95% confidence intervals of the estimate. Lower standard error bar above 0 indicates that active treatment produced a greater peak VO2 compared with placebo. Abbreviations: Q‐ter, coenzyme Q10 terclatrate; VO2, oxygen consumption.

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