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)

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 + 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–IIIb, with an apnoea-hypopnoea index (AHI) > 15/h, and enrolled in a cardiac rehabilitation programme, were centrally randomized to V + 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 (VO_2peak) at the end of the cardiac rehabilitation programme. Results: Fifty-eight patients were randomized to V + ET and 60 patients to ET. The median increase in VO_2peak was 15% [interquartile range 6–36%] in the V + ET group and 16% [0–31%] in the ET group (P = 0.34). AHI decreased in both groups, but significantly more in the V + 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 + 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 + 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.