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Auto-servoventilation in heart failure with sleep apnoea: a randomised controlled trial |
Arzt M, Schroll S, Series F, Lewis K, Benjamin A, Escourrou P, Luigart R, Kehl V, Pfeifer M |
The European Respiratory Journal 2013 Nov;42(5):1244-1254 |
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* |
We tested the hypotheses that in patients with congestive heart failure (CHF) and sleep disordered breathing (SDB) auto-servoventilation (ASV) improves cardiac function and quality of life. Between March 2007 and September 2009, patients with stable CHF (left ventricular ejection fraction (LVEF) <= 40%) and SDB (apnoea/hypopnoea index >= 20 events/h were randomised to receive either ASV (BiPAP ASV (Philips Respironics, Murrysville, PA, USA), n = 37) and optimal medical management, or optimal medical management alone (n = 35). Outcomes were assessed at baseline and 12 weeks. The apnoea/hypopnoea index assessed with polysomnography scored in one core laboratory was significantly more reduced in the ASV group (-39 +/- 16 versus -1 +/- 13 events/h; p < 0.001) with an average use of 4.5 +/- 3.0 h/day. Both groups showed similar improvements of the primary end-point LVEF (+3.4 +/- 5 versus +3.5 +/- 6%; p = 0.915) assessed with echocardiography. In the ASV group, reduction of N-terminal pro-brain natriuretic peptide (NT-proBNP) was significantly greater (-360 +/- 569 versus +135 +/- 625 ng/mL; p = 0.010). No differences were observed between the groups in subjective quality of life. In patients with CHF and SDB, ASV reduced NT-proBNP levels, but improvement of LVEF or quality of life was not greater than in the control group. The data support that such patients can be randomised in large-scale, long-term trials of positive airway pressure therapy versus control to determine effects on cardiovascular outcome.
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