Sobirin 2019.
Study characteristics | ||
Methods | unblinded, randomised controlled clinical trial with parallel design | |
Participants | 30 participants with clinical heart failure were randomised. Inclusion criteria: age ≥ 45 years, NYHA functional status II to IV, EF ≥ 50%, evidence of diastolic dysfunction on non‐invasive imaging, and who had received standard heart failure treatment for 4 weeks before the study Exclusion criteria: chronic atrial fibrillation, acute coronary syndrome or coronary revascularisation within 60 days, clinically significant valvular disease, significantly low systolic blood pressure (< 100 mmHg) or high blood pressure, people with a prior LVEF < 40%, known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease, dyspnoea or oedema due to non‐cardiac causes, such as pulmonary disease, and anaemia (Hb < 8.0 g/dL), inability or refusal to provide informed consent, poor echocardiographic recordings 15 participants were randomised to coenzyme Q10 group and 15 participants to the control group |
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Interventions | Intervention with dose: oral coenzyme Q10 100 mg three times a day + conventional therapy Control: conventional therapy alone |
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Outcomes | Outcomes measured at 30 days Used in this review: left ventricular ejection fraction measured by echocardiography Not used in this review (not outcomes of interest): parameters for diastolic function (E/e' ratio, medial and lateral e', E velocity, E/A velocity ratio, deceleration t and LAVI), diastolic and systolic left ventricle internal diameter. left ventricular mass index |
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Notes | 1 participant in the treatment group and 1 participant in the control group were lost to follow‐up, and were excluded from the analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | study is randomised; randomisation done by permuted blocks with a ratio of 1:1 |
Allocation concealment (selection bias) | Unclear risk | Details about allocation concealment were not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study was unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study was unblinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of the randomised participants, 2 participants were not included in the analysis |
Selective reporting (reporting bias) | High risk | Some outcomes listed in the protocol were not reported in the manuscript (plasma malondialdehyde level, quality of life was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ)) |
Other bias | Low risk | No other risk of bias was found |