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

Adamyan 2008.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: No information
Run‐in period: No information
Intervention time: 90 days
Follow‐up: At 30 days and 90 days
Setting: No information
Participants Type of heart failure: End stage of HF
N = 145 participants (ivabradine: 70; SC: 75)
Mean age: 58 ± 7 years
Gender: 109 (75%) male, 36 (25%) female
Severity of condition: HFrEF < 35%
Inclusion criteria:
  • Postinfarction end‐stage HF

  • NYHA class IV (EF < 35%)

  • Inappropriate HR (91 ± 4 bpm)

  • Intolerance beta‐blockers

  • Treatment with SC


Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine 7.5 mg twice a day
Comparison: SC
Concomitant medications:
  • Digoxin

  • Spironolacton

  • ACE receptor‐blocker or AT1 receptor‐blocker

  • Furosemide


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, 30, 90]
  • Time of standard therapy segment depressions ≥ 1 mm and ≥ 1 mm duration

  • HRV as standard deviation of normal RR intervals by 24‐hour echocardiography monitoring

  • End diastolic volume

  • Tissue Doppler patterns

  • Early diastolic tissue velocity of LV lateral mitral annulus

  • Myocardial performance index

  • Exercise time before stress‐ECG test

  • Exercise time after stress‐ECG test

  • Stroke volume index before stress‐ECG test

  • Stroke volume index after stress‐ECG test


Conclusion:
  • Noticeable side effects requiring the withdrawal of drugs were not observed.

  • Thus, in participants with postinfarction HF NYHA class IV and BB intolerance, addition of ivabradine to SC further improves cardiac parameters in terms of LV remodeling, contractility and ischaemia, and reduces hospitalisation rate probably through HR control.

Notes Funding for trial: No information
Notable conflicts of interest of authors: No information
Contact to authors/unpublished data: We contacted KG Adamyan and S Grigoryan via email on 22 November 2018 to ask for funding, country, number of centres, and missing data. The email to KG Adamyan failed, but S Grigoryan answered that she had forwarded the email to the correct email address. Nevertheless, 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) Unclear risk Insufficient information to base judgement
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding possible due to comparison with standard care.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Insufficient information to base judgement
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Insufficient information to base judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to base judgement
Other bias Unclear risk Insufficient information to base judgement