Summary of findings 3. Usual care with ivabradine compared to placebo, usual care, or no treatment in participants with HFpEF (long‐term treatment (≥ 6 months) with ivabradine).
| Usual care with ivabradine compared to placebo, usual care, or no treatment in participants with HFpEF (long‐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: long‐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 patients with HFpEF (long‐term treatment (≥ 6 months) with ivabradine) | ||||
| Mortality from cardiovascular causes | Komajda 2017: 1 death from cardiovascular cause occurred in the ivabradine group (ischaemic stroke); no deaths occurred in the control group. | 178 (1 RCT) | ⊕⊕⊝⊝ LOW 1, 2 | ||
| Quality of life |
Komajda 2017 No significant improvement (no further details available) |
179 (1 RCT) |
⊕⊕⊝⊝ LOW1, 2 | ||
| 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 | Komajda 2017: No significant difference in improvement (35.1% vs 25.0%) (P = 0.191) | 179 (1 RCT) |
⊕⊕⊝⊝ LOW 1, 2 | ||
| Exercise capacity | Komajda 2017: No significant improvement for ivabradine group in 6‐minute walk test (change of last postbaseline value from baseline: +0.0 m vs +11.0 m) (P = 0.882) | 179 (1 RCT) |
⊕⊕⊝⊝ 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 | |||||
| GRADE Working Group grades of evidence 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 for imprecision (low number of participants). 2Downgraded by one level due to risk of bias (serious methodological limitations due to insufficient information on random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting).