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 |
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Participants |
Type of heart failure: Ischaemic HF N = 158 (ivabradine: 78; SC: 80) Mean age:
Gender:
Severity of condition: LVEF < 40% Inclusion criteria: Stable, ischaemic HF Exclusion criteria: No information Withdrawals: No information |
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Interventions |
Intervention: Ivabradine 5 mg twice a day Comparison: SC Concomitant medications: No information Excluded medications: No information |
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Outcomes |
Outcomes and time points measured in the study: [Month 0, 6]
Conclusion:
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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 (S Bansal on 2 December 2018 via email) Notable conflicts of interest of authors: No information Unpublished data: Information about the trial's funding, way of randomisation, age, sex, NYHA, and EF was provided via email by S Bansal on 2 December 2018. Contact to authors/unpublished data: We contacted S Bansal via email on 22 November 2018 to ask for funding, way of randomisation, age, sex, NYHA, EF, and missing data.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. |
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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) |