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).