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

Clinical cardiology
April 1, 2011
Stefano Fumagalli et al. (9 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine whether oral supplementation with CoQ10 (Q-ter) and creatine could improve exercise tolerance and quality of life in patients with chronic heart failure (CHF) by addressing mitochondrial dysfunction.

Results Summary

The study found that the active treatment group (Q-ter + creatine) showed a significant improvement in peak oxygen consumption (VO2) compared to placebo, suggesting a beneficial effect on physical performance in stable systolic CHF. No adverse effects were reported in either group.

Population

Patients with stable CHF secondary to left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 35%).

Effective Dosage

Q-ter 320 mg + creatine 340 mg once daily.

Duration

8 weeks.

Interactions

None mentioned.

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Oral supplementation with coenzyme Q(10) (CoQ(10)) and creatine
decrease
mitochondrial dysfunction that contributes to impaired physical performance
patients with chronic heart failure (CHF)
-
may reduce
#1
a mixture of water-soluble CoQ(10) (CoQ(10) terclatrate; Q-ter) and creatine
neutral
exercise tolerance and health-related quality of life
patients with CHF secondary to left ventricular systolic dysfunction (left ventricular ejection fraction ≤ 35%)
-
determine the effect
#2
Q-ter 320 mg + creatine 340 mg
increase
8-week peak VO(2)
patients with stable CHF
+1.8 ± 0.9 mL/min/kg, 95% CI: 0.1-3.6
significantly higher
#3
Q-ter 320 mg + creatine 340 mg
no change
safety
patients with stable CHF
-
No untoward effects occurred
#4
oral Q-ter and creatine, added to conventional drug therapy
increase
physical performance
patients with stable systolic CHF
-
exert some beneficial effect
#5
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.

Medical Subject Headings (MeSH)
Administration, OralAgedChi-Square DistributionChronic DiseaseCreatineDeficiency DiseasesDietary SupplementsDouble-Blind MethodDrug CombinationsExercise TestExercise ToleranceFemaleHeart FailureHumansMaleMedication AdherenceOxygen ConsumptionPlacebo EffectQuality of LifeStroke VolumeTime FactorsTreatment OutcomeUbiquinoneVentricular Function, Left
Study Links
Quality Scores
Safety90
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations32
Citations/Year2.3
Relative Citation Ratio1.19
NIH Percentile56.7%
Research Impact Scores
APT Score0.50
Weight Score1.43
Normalized Score0.83
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