Sarullo 2010.
Study characteristics | ||
Methods |
Study design: RCT Unit of randomisation: No information Total duration of study: No information Run‐in period: No information Intervention time: 3 months Follow‐up: 3 months Setting: Buccheri La Ferla‐Fatebenefratelli Hospital, Palermo, Italy (F Sarullo via email on 22 November 2018) |
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Participants |
Type of heart failure: Ischaemic HF N = 60 participants (ivabradine and BB: 30; placebo: 30) Mean age:
Gender:
Severity of condition: LVEF ≤ 40% Inclusion criteria:
Exclusion criteria:
Withdrawals: No information |
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Interventions |
Intervention:
Comparison: Placebo Concomitant medications:
Excluded medications: No information |
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Outcomes |
Outcomes and time points measured in the study: [Day 0, Month 3]
Conclusion: "The "Off‐Label" use of ivabradine significantly improves the exercise capacity, gas exchange, functional HF class, quality of life, and neurohormonal modulation in pts with ischemic CHF" |
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Notes |
Funding for trial: "The authors received no financial support for the research and/or authorship of this article." Notable conflicts of interest of authors: "The authors declare no conflicts of interest with respect to the authorship and/or publication of this article." Contact to authors/unpublished data: We contacted F Sarullo via email on 22 November 2018 to ask for way of randomisation, number of centres, country, and missing data. F Sarullo answered on 22 November 2018, providing the information about randomisation, number of centres, country, and that no other unpublished data were available. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The procedure of randomization to receive either ivabradine 5 mg or placebo twice daily was performed by computerized sequence generation. " (F Sarullo via email on 22 November 2018) |
Allocation concealment (selection bias) | Low risk | "The tablets of ivabradine and placebo were prepared and placed before the randomization in numbered anonymous bottles." (F Sarullo via email on 22 November 2018) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "The single blind design was carried out..." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding. However, the measured outcomes are objective outcomes (mortality, length of stay, etc.) and thus not likely to be influenced by lack of blinding. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information to base judgement |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods section were adequately reported or explained in the results. |
Other bias | Low risk | "The authors received no financial support for the research and/or authorship of this article." |