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

De Masi De Luca 2013.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: 3 months
Run‐in period: No information
Intervention time: No information
Follow‐up: No information
Setting: No information
Participants Type of heart failure: CHF
N = 111 participants (ivabradine: 53; placebo: 58)
Mean age: 61 ± 13 years (no SD reported)
Gender: 78 (70%) male, 33 (30%) female
Severity of condition: LVEF ≥ 50%
Inclusion criteria:

  • HFnEF

  • NYHA II/IV

  • HR > 70 bpm

  • LVEF ≥ 50%


Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine 5 to 7.5 mg twice a day
Comparison: Placebo
Concomitant medications: SC
Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Day 0, 3 months]

  • Clinical examination (NYHA class)

  • Cardiopulmonary test

    • pulmonary venous oxygen tension

    • exercise duration

  • NT‐pro‐BNP


Conclusion: "Thus the data of our study suggest that the addition of Ivabradine to optimal medical treatment for the HFNF improves physical performance and neurohormonal parameters"
Notes Funding for trial: No information
Notable conflicts of interest of authors: No information
Contact to authors/unpublished data: We contacted G de Masi de Luca via email on 22 November 2018 to ask for funding, country, number of centres, duration IP administration, and missing data. 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 Unclear risk Insufficient information to base judgement
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