Summary of findings 2. Mineralocorticoid receptor antagonists (MRAs) compared to placebo or no treatment for chronic heart failure with preserved ejection fraction.
| MRAs compared to placebo or no treatment for chronic heart failure with preserved ejection fraction | ||||||
| Patient or population: patients with chronic heart failure with preserved ejection fraction Setting: secondary care Intervention: MRAs Comparison: placebo or no treatment | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo or no treatment | Risk with MRAs | |||||
| Cardiovascular mortality (RR) follow‐up: range 12 months to 3.3 years | Study population | RR 0.90 (0.74 to 1.11) | 4070 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | Two additional trials (RAAM‐PEF; Kurrelmeyer 2014) reported that no deaths occurred | |
| 88 per 1000 | 79 per 1000 (65 to 97) | |||||
| Heart failure hospitalisation (RR) follow‐up: range 24 weeks to 3.3 years | Study population | RR 0.82 (0.69 to 0.98) | 3714 (3 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | Three additional trials (ALDO‐DHF; Kurrelmeyer 2014; Upadhya 2017) reported that no hospitalisation due to heart failure occurred | |
| 136 per 1000 | 112 per 1000 (94 to 134) | |||||
| Hyperkalaemia follow‐up: range 24 weeks to 3.3 years | Study population | RR 2.11 (1.77 to 2.52) | 4291 (6 RCTs) | ⊕⊕⊕⊕ HIGH | Two trials defined hyperkalaemia ≥ 5.5 mEg/L | |
| 83 per 1000 | 175 per 1000 (146 to 208) | |||||
| All‐cause mortality follow‐up: range 9 months to 3.3 years | Study population | RR 0.91 (0.78 to 1.06) | 4207 (5 RCTs) | ⊕⊕⊕⊝ MODERATE 1 | Two additional trials (RAAM‐PEF; Kurrelmeyer 2014) reported that no deaths occurred | |
| 133 per 1000 | 121 per 1000 (104 to 141) | |||||
| Quality of life (MLHFQ): from 0 to 105 follow‐up: range 9 months to 12 months | Mean quality of life (MLHFQ) ranged from 20 to 25 | MD 0.84 higher (2.30 lower to 3.98 higher) | ‐ | 511 (3 RCTs) | ⊕⊕⊝⊝ LOW 2 3 | Lower = better, 5 points are considered a clinically significant difference We did not pre‐specify which QoL scale was to be reported in the 'Summary of findings' table. To aid comparisons among 'Summary of findings' tables we chose to include the Minnesota Living with Heart Failure questionnaire and not the SMD across two scales |
| *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; MD: Mean difference; MLHFQ: Minnesota Living with Heart Failure Questionnaire; MRAs: Mineralocorticoid receptor antagonists; RCT: Randomised controlled trial; RR: Risk ratio | ||||||
| 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 due to imprecision.
2Downgraded by one level due to study limitations (one trial was open label).
3Downgraded by one level due to imprecision (small sample size).