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. 2020 Nov 4;2020(11):CD013004. doi: 10.1002/14651858.CD013004.pub2

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
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:
  • Sinus rhythm

  • > 3‐month history of MI

  • EF < 40%

  • HR ≥ 60 bpm

  • NYHA II‐III


Exclusion criteria:
  • Revascularisation of myocardium conducted during the past 6 months

  • Existence of an indication for a revascularisation emergency surgery

  • Stroke or temporary disturbances in cerebral perfusion during the past 3 months

  • Implanted artificial pacemaker or cardioverter defibrillator

  • Heart valve defect with a high chance of surgical treatment during the course of the following 3 years

  • Sinus node weakness

  • Sinoatrial block

  • Long QT syndrome

  • Atrioventricular block


Withdrawals: 6 withdrawals (12%)
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:
  • BB (85.7%)

  • ACE inhibitor (96%)


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, Year 3.5]
  • HR

  • BP

  • Parameters of ECG

  • Levels of electrolytes

  • Creatinin in blood plasma

  • Frequency of hospitalisations

  • Recurrent non‐fatal MI and lethality (combined endpoint)


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."
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.
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