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| Is ventilatory therapy combined with exercise training effective in patients with heart failure and sleep-disordered breathing? Results of a randomized trial during a cardiac rehabilitation programme (SATELIT-HF) |
| Iliou MC, Corone S, Gellen B, Denolle T, Roche F, Nelson AC, Darne C |
| Archives of Cardiovascular Diseases 2018 Oct;111(10):573-581 |
| clinical trial |
| 6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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BACKGROUND: Sleep-related disordered breathing is common in patients with chronic heart failure. AIM: To assess the efficacy of short-term nocturnal ventilatory therapy combined with exercise training (V plus ET) compared with exercise training alone (ET) in patients with chronic heart failure with sleep-disordered breathing. METHODS: Patients in New York Heart Association functional class II to IIIb, with an apnoea-hypopnoea index (AHI) > 15/h, and enrolled in a cardiac rehabilitation programme, were centrally randomized to V plus ET or ET. Subjects were classified as having obstructive sleep apnoea (OSA) (n = 49) or central sleep apnoea (CSA)/mixed (n = 69). The primary outcome was the change in the 10-second average oxygen consumption at maximum exercise (VO2peak) at the end of the cardiac rehabilitation programme. RESULTS: Fifty-eight patients were randomized to V plus ET and 60 patients to ET. The median increase in VO2peak was 15% (interquartile range 6 to 36%) in the V+ET group and 16% (0 to 31%) in the ET group (p = 0.34). AHI decreased in both groups, but significantly more in the V plus ET group (p = 0.006). The decrease in the ventilatory efficiency (VE/VCO2) slope was not statistically different between the two-randomization groups (p = 0.10). In subjects with CSA, the VE/VCO2 slope decreased significantly more in the V plus ET group (p = 0.03), while there was no difference between the two-randomization groups in subjects with OSA (p = 0.75). Six cardiovascular events occurred in patients with OSA (all randomized to the ET group); in subjects with CSA, two events occurred in the V plus ET group and three in the ET group. CONCLUSIONS: Short-term nocturnal ventilation combined with exercise training does not increase the exercise capacity of patients with chronic heart failure.
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