Skip to main content
. 2020 Nov 4;2020(11):CD013004. doi: 10.1002/14651858.CD013004.pub2

Tumasyan 2016.

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 years
Follow‐up: No information
Setting: Institute of Cardiology, Yerevan, Armenia
Participants Type of heart failure: CHF, LV‐dysfunction
N = 106 (ivabradine and BB: 53; SC: 53)
Mean age: 57.4 ± 0.4 years
Gender: No information
Severity of condition: HFrEF < 40%
Inclusion criteria: NYHA class III‐IV
Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine max. 7.5 mg twice a day
Comparison: SC
Concomitant medications:
  • ACE inhibitors

  • BB

  • Digoxin

  • Diuretics


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[0 d, 3, 6, 12, 24, 36 months]
  • Mortality

  • Hospitalisation rate

  • RV EF

  • Fractional area change

  • Tricuspid annulus plane systolic excursion

  • RA and LA functional index

  • Fractional contribution

  • Relation of pulmonary vein

  • Systolic and diastolic fraction

  • Systolic contribution

  • Difference between duration of reversal atrial flow and late transmittal filling

  • Pulmonary artery ejection time

  • BNP

  • NT‐pro‐BNP

  • C‐reactive protein levels


Conclusion:
  • Decrease of BNP, NT‐pro‐BNP ≥ 50%, C‐reactive protein levels and changes in duration of reversal atrial flow and late transmittal filling ≥ 40%, HR ≥ 30% and increase of RA and LA functional index ≥ 80%, fractional contribution, RV EF and fractional area change ≥ 40%, pulmonary vein systolic contribution ≥ 50% identified pts with cardiac events reduction

  • Ivabradine use associated with lower mortality and morbidity due to significant improvement of right heart and LA functional parameters, neurohormonal and inflammation status, and HR reduction

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Contact to authors/unpublished data: We contacted KG Adamyan and S Grigoryan via email on 22 November 2018 to ask for funding, country, number of centres, and missing data.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 Blinding impossible 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 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