Potapenko 2011.
Study characteristics | ||
Methods |
Study design: RCT Unit of randomisation: No information Total duration of study: No information Run‐in period: No information Intervention time: 3.5 years Follow‐up: 36.1 ± 6.2 months Setting: University of Peoples' Friendship Moscow; City Hospital N64 |
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Participants |
Type of heart failure: MI with systolic CHF N = 49 participants (ivabradine and beta‐blockers: 23; SC: 26) Mean age: 63.1 ± 8.1 years Gender: 40 (81.6%) male, 9 (18.4%) female Severity of condition: No information Inclusion criteria:
Exclusion criteria:
Withdrawals: 6 withdrawals (12%) |
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Interventions |
Intervention: Ivabradine (initial dose 5 mg twice a day; after 2 weeks with a heart rate of 60/min or higher: 7.5 mg twice a day; if heart rate dropped below 50/min or other clinical symptoms of bradycardia: again 5 mg twice a day; if symptoms did not improve: ivabradine treatment stopped) Comparison: SC Concomitant medications:
Excluded medications: No information |
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Outcomes |
Outcomes and time points measured in the study: [Day 0, Year 3.5]
Conclusion: "In the same trend in BP and Echocardiography, group 1 (Ivabradine) patients showed significant and more pronounced HR lowering than group 2 patients. Addition of ivabradine to standard treatment of systolic chronic cardiac failure after MI promoted less frequency of hospitalizations, recurrent non‐fatal MI, fatal cardiovascular events. This effect was especially strong in high baseline HR." |
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Notes |
Funding for trial: No information Notable conflicts of interest of authors: No information Contact to authors/unpublished data: We contacted AV Potapenko via email on 22 November 2018 to ask for an English publication. We did not receive an answer. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information to base judgement |
Allocation concealment (selection bias) | Low risk | "The procedure of randomization to receive either ivabradine or SC was performed by sealed envelopes." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding possible due to comparison with SC. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information to base judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Less than 20% missing data. Outcomes reported for 42 of 49 participants (88%). |
Selective reporting (reporting bias) | Low risk | All outcomes stated in the methods section were adequately reported or explained in the results. |
Other bias | Unclear risk | Insufficient information to base judgement |