Circulation Journal
Online ISSN : 1347-4820
Print ISSN : 1346-9843
Late Breaking Clinical Trials (JCS 2015)
Adaptive Servo-Ventilation Therapy for Patients With Chronic Heart Failure in a Confirmatory, Multicenter, Randomized, Controlled Study
Shin-ichi MomomuraYoshihiko SeinoYasuki KiharaHitoshi AdachiYoshio YasumuraHiroyuki YokoyamaHiroshi WadaTakayuki IseKoichi Tanakafor the SAVIOR-C investigators
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2015 Volume 79 Issue 5 Pages 981-990

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Abstract

Background:Adaptive servo-ventilation (ASV) therapy is expected to be novel nonpharmacotherapy with hemodynamic effects on patients with chronic heart failure (CHF), but sufficient evidence has not been obtained.Methods and Results:A 24-week, open-label, randomized, controlled study was performed to confirm the cardiac function-improving effect of ASV therapy on CHF patients. At 39 institutions, 213 outpatients with CHF, whose left ventricular ejection fraction (LVEF) was <40% and who had mild to severe symptoms [New York Heart Association (NYHA) class: ≥II], were enrolled. After excluding 8 patients, 102 and 103 underwent ASV plus guideline-directed medical therapy (GDMT) [ASV group] and GDMT only [control group], respectively. The primary endpoint was LVEF, and the secondary endpoints were HF deterioration, B-type natriuretic peptide (BNP), and clinical composite response (CCR: NYHA class+HF deterioration). LVEF and BNP improved significantly at completion against the baseline values in the 2 groups. However, no significant difference was found between these groups. HF deterioration tended to be suppressed. The ASV group showed a significant improvement in CCR corroborated by significant improvements in NYHA class and ADL against the control group.Conclusions:Under the present study’s conditions, ASV therapy was not superior to GDMT in the cardiac function-improving effect but showed a clinical status-improving effect, thus indicating a given level of clinical benefit. (Circ J 2015; 79: 981–990)

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© 2015 THE JAPANESE CIRCULATION SOCIETY
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