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

Chaudhari 2014.

Study characteristics
Methods Study design: RCT
Unit of randomisation: No information
Total duration of study: No information
Run‐in period: No information
Intervention time: 6 months
Follow‐up: At 6 months
Setting: Monocenter, Safdarjang Hospital and Vardhman Mahavir Medical College, New Delhi, India
Participants Type of heart failure: Ischaemic HF
N = 158 (ivabradine: 78; SC: 80)
Mean age:
  • Ivabradine: 57.52 ± 9.3 years

  • Standard care: 59.47 ± 8.3 years (S Bansal on 2 December 2018 via email)


Gender:
  • Ivabradine: 70 (89.74%) male

  • Standard care: 65 (81.25%) male (S Bansal on 2 December 2018 via email)


Severity of condition: LVEF < 40%
Inclusion criteria: Stable, ischaemic HF
Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine 5 mg twice a day
Comparison: SC
Concomitant medications: No information
Excluded medications: No information
Outcomes Outcomes and time points measured in the study:
[Month 0, 6]
  • LV dimension

  • LVEF

  • Exercise duration (in seconds)

  • Quality of life score assessment by KCCQ

  • Serum BNP level


Conclusion:
  • There was no significant difference in mortality and morbidity with ivabradine therapy in patients with heart failure in whom betablockers were contraindicated. Hospitilisation was more or less same in both the groups.

Notes Funding for trial: "Our hospital is a federal government university teaching hospital. The diagnosis and treatment are free. However, free samples of Ivabradine were provided by an Indian company – M/S Cipla Private Limited, an Indian pharmaceutical company." (S Bansal on 2 December 2018 via email)
Notable conflicts of interest of authors: No information
Unpublished data: Information about the trial's funding, way of randomisation, age, sex, NYHA, and EF was provided via email by S Bansal on 2 December 2018.
Contact to authors/unpublished data: We contacted S Bansal via email on 22 November 2018 to ask for funding, way of randomisation, age, sex, NYHA, EF, and missing data. S Bansal answered on 2 December 2018 providing information about funding, way of randomisation, age, sex, NYHA, EF, and other additional outcomes such as BNP levels.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk "Simple manual (non computer based) randomization was used. Every third individual in the outpatient clinic who satisfied the inclusion criteria was considered for Ivabradine add‐on therapy over and above GDMT." (S Bansal on 2 December 2018 via email)
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 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 "Our hospital is a federal government university teaching hospital. The diagnosis and treatment are free. However, free samples of Ivabradine were provided by an Indian company – M/S Cipla Private Limited, an Indian pharmaceutical company." (S Bansal on 2 December 2018 via email)