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

Summary of findings 4. Usual care with ivabradine compared to placebo, usual care, or no treatment in participants with HFpEF (short‐term treatment (< 6 months) with ivabradine).

Usual care with ivabradine compared to placebo, usual care, or no treatment in participants with HFpEF (short‐term treatment (< 6 months) with ivabradine)
Patient or population: adults (≥ 18 years of age) with a diagnosis of chronic heart failure with a preserved ejection fraction (HFpEF)
Setting: hospital or outpatient care
Intervention: short‐term treatment (< 6 months) with ivabradine
Comparison: placebo, usual care, or no treatment
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) № of participants
(studies) Certainty of the evidence
(GRADE)
Risk with placebo Risk with usual care with ivabradine compared to placebo, usual care, or no treatment in participants with HFpEF (short‐term treatment (< 6 months) with ivabradine)
Mortality from cardiovascular causes (follow‐up range 19 to 23 months) Not reported in studies that met the inclusion criteria for this comparison
Quality of life Not reported in studies that met the inclusion criteria for this comparison
Time to first hospitalisation for heart failure during follow‐up Not reported in studies that met the inclusion criteria for this comparison
Number of days spent in hospital due to heart failure during follow‐up Not reported in studies that met the inclusion criteria for this comparison
Rate of serious adverse events Not reported in studies that met the inclusion criteria for this comparison
Exercise capacity De Masi De Luca 2013: Significant improvement for ivabradine in exercise duration (baseline: 5.4 ± 2.1 min vs follow‐up at month 3: 6.9 ± 2.9 min) (P < 0.05). No data for placebo group.
Kosmala 2013: Significant improvement for ivabradine group (baseline: 4.2 ± 1.8 metabolic equivalents vs follow‐up at day 7: 5.7 ± 1.9 metabolic equivalents) (P = 0.001). "No change in the control subjects."
171
(2 RCTs)
⊕⊕⊝⊝
LOW 1, 2
Economic costs Not reported in studies that met the inclusion criteria for this comparison
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; HFpEF: heart failure with a preserved ejection fraction; RCT: randomised controlled trial
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

1Downgraded by one level due to inconsistency (heterogeneity in parameters).
2Downgraded by one level due to imprecision (low number of participants).