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

Bansal 2019.

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: Safdarjung Hospital, New Delhi, India
Participants Type of heart failure: Ischaemic heart failure with systolic dysfunction
N = 309 (ivabradine: 157, SC: 152)
Mean age: No information
Gender: No information
Severity of condition: No information
Inclusion criteria: No information
Exclusion criteria: No information
Withdrawals: No information
Interventions Intervention: Ivabradine
Comparison: SC
Concomitant medications: Optimal medical therapy
Excluded medications: No information
Outcomes Outcomes and time points measured in the study:

  • Left ventricular dimension

  • Left ventricular ejection fraction

  • Exercise duration (in seconds)

  • Serum BNP level

  • Sodium level


Conclusion:
"Patients in low serum sodium levels at baseline had lower ejection fraction, exercise duration and higher BNO level and LV end‐systolic and end‐diastolic dimensions in both groups as compared to patients with higher serum Sodium values. Serum sodium may serve as a simple clue to lower EF, higher BNP and poorer effort tolerance in stable patients of ischemic systolic heart failure"
Notes Funding for trial: Medication is funded by the government
Notable conflicts of interest of authors: No information
Contact to authors/unpublished data: No
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 Low risk Less than 20% missing data. Outcomes reported for 309 of 309 participants (100%).
Selective reporting (reporting bias) Unclear risk Insufficient information to base judgement
Other bias Unclear risk Insufficient information to base judgement