Martin R Cowie1, Holger Woehrle2,3, Karl Wegscheider4, Eik Vettorazzi4, Susanne Lezius4, Wolfgang Koenig5,6,7, Frank Weidemann8,9, Gillian Smith10, Christiane Angermann11, Marie-Pia d'Ortho12, Erland Erdmann13, Patrick Levy14, Anita K Simonds10, Virend K Somers15, Faiez Zannad16, Helmut Teschler17. 1. Imperial College London, London, UK. 2. ResMed Science Centre, ResMed Germany Inc., Martinsried, Germany. 3. Sleep and Ventilation Center Blaubeuren, Respiratory Center Ulm, Ulm, Germany. 4. Department of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany. 5. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 6. DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany. 7. Department of Internal Medicine II-Cardiology University of Ulm Medical Center, Ulm, Germany. 8. Department of Medicine I, University and University Hospital Würzburg, Würzburg, Germany. 9. Katharinen-Hospital Unna, Unna, Germany. 10. Royal Brompton Hospital, London, UK. 11. Comprehensive Heart Failure Center, University Hospital and University of Würzburg, Würzburg, Germany. 12. University Paris Diderot, Sorbonne Paris Cité, Hôpital Bichat, Explorations Fonctionnelles, DHU FIRE, AP-HP, Paris, France. 13. Heart Center, University of Cologne, Cologne, Germany. 14. CHU de Grenoble, Grenoble, France. 15. Mayo Clinic and Mayo Foundation, Rochester, MN, USA. 16. Inserm, Université de Lorraine, CHU, Nancy, France. 17. Department of Pneumology, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.
Abstract
AIMS: The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. METHODS AND RESULTS: In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminalpro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. CONCLUSION: In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.
RCT Entities:
AIMS: The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. METHODS AND RESULTS: In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. CONCLUSION: In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.
Authors: Meghna P Mansukhani; Bhanu Prakas Kolla; James M Naessens; Peter C Gay; Timothy I Morgenthaler Journal: J Clin Sleep Med Date: 2019-01-15 Impact factor: 4.062
Authors: Adrian V Hernandez; Anne Jeon; Jack Denegri-Galvan; Fernando Ortega-Loayza; Monica Felix-Moscoso; Vinay Pasupuleti; Roop Kaw Journal: Sleep Breath Date: 2019-07-03 Impact factor: 2.816
Authors: Christoph Fisser; Jannis Bureck; Lara Gall; Victoria Vaas; Jörg Priefert; Sabine Fredersdorf; Florian Zeman; Dominik Linz; Holger Wöhrle; Renaud Tamisier; Helmut Teschler; Martin R Cowie; Michael Arzt Journal: ERJ Open Res Date: 2021-08-02