Sousonis 2014.
| Study characteristics | ||
| Methods | Single centre randomised controlled trial Setting: Patients with heart failure and with more than 7000 PVCs/24 h Country: Greece |
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| Participants | N = 20 (10 amiodarone + standard medical therapy, 10 standard medical therapy) Sex: 80‐100% male Age: mean 59‐62 years Inclusion: consecutive HF patients (LVEF ≤ 40%, mean LVEF: 31 ± 7%) with more than 7000 PVCs/24 h (primary prevention) |
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| Interventions | Group 1: amiodarone (200 mg/d) + standard medical therapy Group 2: standard medical therapy alone Duration: 6 months |
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| Outcomes | All‐cause mortality, cardiac mortality, SCD | |
| Notes | Presented as a poster in the 2014 Heart Failure Congress, we have unpublished data given to us by the author. At 6 months follow‐up, only 8 patients´s status was known in the control group. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from the author: "a total of 20 consecutive patients were randomised in a 1:1 treatment allocation" |
| Allocation concealment (selection bias) | Unclear risk | The trial was randomised, but allocation concealment wasn't described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from the author: "Only the 24 h Holter overreading physician was blinded during the study." |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | From the author: The outcome assessor was not blind to the group which the patients were assigned to. |
| Incomplete outcome data (attrition bias) Objective outcomes (death) | High risk | There were 2 patients lost in the control group at the 6‐month follow‐up |
| Incomplete outcome data (attrition bias) Subjective outcomes (quality of life) | Unclear risk | No description regarding any aspect of any subjective outcome |
| Selective reporting (reporting bias) | Low risk | The study protocol was not available, but it is clear that the published report includes all expected outcomes |
| Other bias | High risk | Due to the small number of participants, it is difficult to adequately consider other confounding factors |