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

Tumasyan 2017.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: No information
Run‐in period: No information
Intervention time: No information
Follow‐up: No information
Setting: No information
Participants Type of heart failure: CHF
N = 165 participants (digoxin: 55; ivabradine and BB: 53; SC: 57)
Mean age: 63.2 years
Gender: No information
Severity of condition: No information
Inclusion criteria:
  • NYHA III

  • Preserved LVEF

  • HR ≥ 70 bpm


Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine max. 7.5 mg twice a day
Comparison:
  • Digoxin 0.25 mg twice a day

  • No treatment


Concomitant medications:
  • ACE inhibitors

  • BB

  • Diuretics


Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, Month 12, 24, and 36]
  • LV, RV, LA, RA atrial parameters

  • NT‐pro‐BNP

  • High sensitivity C‐reactive protein levels

  • RV fractional area change

  • Tricuspid annulus plane systolic excursion

  • Pulmonary artery ejection time

  • RA and LA functional index

  • Relation of pulmonary vein systolic and diastolic fraction

  • PV systolic contribution

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


Conclusion:
  • Changes of duration of reversal atrial flow and late transmittal filling ≥ 80%, RA and LA functional index, PV systolic contribution ≥ 50%, NT‐pro‐BNP, high sensitivity C‐reactive protein levels ≥ 40%; pulmonary artery ejection time and HR ≥ 25% identified pts with hospitalisation risk reduction

  • Ivabradine and digoxin use associated with similar significant reduction of morbidity and trend of reduction of mortality due to significant improvement of RV, LA and RA 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Contact to authors/unpublished data: We contacted KG Adamyan and S Grigoryan via email on 22 November 2018 to ask for funding, country, number of centres, and missing data.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