Tier 3 — preclinical

Coenzyme Q10 in the Treatment of Heart Failure with Preserved Ejection Fraction: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Tal Y Samuel, Tal Hasin, Israel Gotsman, Tanya Weitzman, Fanny Ben Ivgi, Ziv Dadon, Elad Asher, Offer Amir, Michael Glikson, Ronny Alcalai, David Leibowitz
Drugs in R&D 2022 22(1):25-33

Bibliography

PubMed
PMID 34826125
PubMed Central
PMC8885873
DOI
10.1007/s40268-021-00372-1
Funding
Partial funding was provided by Kaneka Co., Japan. The paper states that the funding source had no role in data collection or manuscript preparation.
Competing interests
The authors reported no conflicts of interest.

Study snapshot

DesignProspective randomized double-blind placebo-controlled trial
ModelAdults older than 55 years with symptomatic NYHA class II-IV heart failure, LVEF above 50%, and impaired diastolic function at two Israeli centers.
Sample39 enrolled: 19 CoQ10 and 20 placebo.
InterventionStabilized ubiquinol 100 mg three times daily (300 mg/day), manufactured and supplied by Kaneka Corporation, versus identical placebo, added to existing medical therapy.
Duration4 months
EndpointsDiastolic tissue Doppler velocities; E/e' ratio; NT-proBNP; Serum CoQ10 concentration; Compliance

What the study showed, in plain terms

This small randomized double-blind trial specifically tested CoQ10 in heart failure with preserved ejection fraction (HFpEF), a population often mixed together with reduced-EF heart failure in broader supplement claims.

Thirty-nine adults received stabilized ubiquinol 300 mg/day or placebo for four months. CoQ10 exposure increased, but treatment did not significantly improve echocardiographic indices of diastolic function or NT-proBNP compared with placebo.

The study is important negative evidence: favorable HFrEF or mixed-heart-failure results should not automatically be generalized to HFpEF.

Key findings

Primary diastolic-function outcome: lateral E/e' changed by -0.86 ± 6.57 with CoQ10 versus +0.18 ± 3.76 with placebo; p=0.561.

NT-proBNP: -72 pg/mL with CoQ10 versus -42 pg/mL with placebo; p=0.195.

Serum CoQ10 increased with active treatment, confirming exposure, but no significant treatment effect was demonstrated on the prespecified cardiac endpoints.

The formulation was stabilized ubiquinol 100 mg three times daily; Q-SYMBIO used ubiquinone at the same total daily dose, so the two trials should not be treated as a direct form comparison.

What this study can and cannot tell us

Pilot-sized trial with only 39 participants, limiting statistical power.

Four months may be too short to assess hospitalization, mortality or other long-term outcomes.

The study focused on surrogate echocardiographic and biomarker endpoints rather than patient-important clinical events.

Kaneka partially funded the study and supplied the stabilized ubiquinol product, although the authors reported no conflicts and stated that the funder had no role in data collection or manuscript preparation.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology