title: Rationale and design of the SERVE-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea with adaptive servo-ventilation in patients with chronic heart failure.
abstract: OBJECTIVE
  Central sleep apnoea/Cheyne-Stokes respiration (CSA/CSR) is a risk factor for increased mortality and morbidity in heart failure (HF). Adaptive servo-ventilation (ASV) is a non-invasive ventilation modality for the treatment of CSA/CSR in patients with HF.
  
  
  METHODS
  SERVE-HF is a multinational, multicentre, randomized, parallel trial designed to assess the effects of addition of ASV (PaceWave, AutoSet CS; ResMed) to optimal medical management compared with medical management alone (control group) in patients with symptomatic chronic HF, LVEF ≤45%, and predominant CSA. The trial is based on an event-driven group sequential design, and the final analysis will be performed when 651 events have been observed or the study is terminated at one of the two interim analyses. The aim is to randomize ∼1200 patients to be followed for a minimum of 2 years. Patients are to stay in the trial up to study termination. The first patient was randomized in February 2008 and the study is expected to end mid 2015. The primary combined endpoint is the time to first event of all-cause death, unplanned hospitalization (or unplanned prolongation of a planned hospitalization) for worsening (chronic) HF, cardiac transplantation, resuscitation of sudden cardiac arrest, or appropriate life-saving shock for ventricular fibrillation or fast ventricular tachycardia in implantable cardioverter defibrillator patients.
  
  
  CONCLUSIONS
  The SERVE-HF study is a randomized study that will provide important data on the effect of treatment with ASV on morbidity and mortality, as well as the cost-effectiveness of this therapy, in patients with chronic HF and predominantly CSA/CSR.
  
  
  BACKGROUND
  ISRCTN19572887.
authors.affiliation: Imperial College London (Royal Brompton Hospital), London, UK. m.cowie@imperial.ac.uk
authors.forename: Martin R
authors.initials: MR
authors.lastname: Cowie
authors.forename: Holger
authors.initials: H
authors.lastname: Woehrle
authors.forename: Karl
authors.initials: K
authors.lastname: Wegscheider
authors.forename: Christiane
authors.initials: C
authors.lastname: Angermann
authors.forename: Marie-Pia
authors.initials: MP
authors.lastname: d'Ortho
authors.forename: Erland
authors.initials: E
authors.lastname: Erdmann
authors.forename: Patrick
authors.initials: P
authors.lastname: Levy
authors.forename: Anita
authors.initials: A
authors.lastname: Simonds
authors.forename: Virend K
authors.initials: VK
authors.lastname: Somers
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.forename: Helmut
authors.initials: H
authors.lastname: Teschler
mesh_terms: D002639:Cheyne-Stokes Respiration / Q000150:complications / Q000628:therapy*; D002908:Chronic Disease; D006333:Heart Failure / Q000150:complications / Q000628:therapy*; D006801:Humans; D011175:Positive-Pressure Respiration / Q000379:methods*; D020182:Sleep Apnea, Central / Q000150:complications / Q000628:therapy*
keywords: Adaptive servo-ventilation; Central sleep apnoea; Heart failure; Randomized controlled trial; Sleep-disordered breathing
references.citation: J Am Coll Cardiol. 2008 Aug 19;52(8):686-717
references.pmid: 18702977
references.citation: Lancet. 2005 Mar 19-25;365(9464):1046-53
references.pmid: 15781100
references.citation: Eur J Heart Fail. 2012 Aug;14(8):803-69
references.pmid: 22828712
references.citation: Biometrics. 1991 Jun;47(2):511-21
references.pmid: 1912258
references.citation: Psychother Psychosom Med Psychol. 2005 Mar-Apr;55(3-4):200-8
references.pmid: 15800814
references.citation: Am J Respir Crit Care Med. 2007 Dec 15;176(12):1274-80
references.pmid: 17673692
references.citation: Eur J Heart Fail. 2007 Mar;9(3):251-7
references.pmid: 17027333
references.citation: Eur J Heart Fail. 2011 Jan;13(1):68-75
references.pmid: 20961913
references.citation: Circulation. 2007 Jun 26;115(25):3173-80
references.pmid: 17562959
references.citation: Am J Respir Crit Care Med. 2001 Aug 15;164(4):614-9
references.pmid: 11520725
references.citation: Eur J Heart Fail. 2007 May;9(5):440-9
references.pmid: 17174152
references.citation: Arch Intern Med. 2006 May 22;166(10):1092-7
references.pmid: 16717171
references.citation: Eur Heart J. 2011 Jan;32(1):61-74
references.pmid: 20846992
references.citation: N Engl J Med. 2005 Nov 10;353(19):2025-33
references.pmid: 16282177
references.citation: Circulation. 2003 Jan 7;107(1):68-73
references.pmid: 12515745
references.citation: Am J Respir Crit Care Med. 2010 Apr 1;181(7):718-26
references.pmid: 20007932
references.citation: JAMA. 2012 May 23;307(20):2161-8
references.pmid: 22618923
references.citation: Eur J Heart Fail. 2012 Sep;14(9):1009-19
references.pmid: 22730336
references.citation: Am J Respir Crit Care Med. 2003 Nov 1;168(9):1109-14
references.pmid: 12928310
references.citation: J Affect Disord. 2004 Jul;81(1):61-6
references.pmid: 15183601
references.citation: Eur Heart J. 2013 Mar;34(11):809-15
references.pmid: 22427382
references.citation: Am J Respir Crit Care Med. 2004 Feb 1;169(3):361-6
references.pmid: 14597482
references.citation: Eur J Heart Fail. 2008 Jun;10(6):581-6
references.pmid: 18486550
references.citation: J Am Coll Cardiol. 2007 May 22;49(20):2028-34
references.pmid: 17512359
references.citation: Circulation. 1999 Dec 7;100(23):2332-5
references.pmid: 10587337
references.citation: Heart. 2006 Mar;92(3):337-42
references.pmid: 15964943
references.citation: Int J Cardiol. 2010 Feb 18;139(1):17-24
references.pmid: 18805598
references.citation: Am J Respir Crit Care Med. 2003 May 1;167(9):1181-5
references.pmid: 12615621
references.citation: Chest. 2012 Nov;142(5):1211-1221
references.pmid: 22722232
references.citation: Chest. 2008 Mar;133(3):690-6
references.pmid: 18198253
references.citation: N Engl J Med. 2003 Mar 27;348(13):1233-41
references.pmid: 12660387
references.citation: Eur Respir J. 2007 Jun;29(6):1201-5
references.pmid: 17360729
references.citation: Lancet. 1981 Apr 18;1(8225):862-5
references.pmid: 6112294
references.citation: Arch Intern Med. 2007 Apr 23;167(8):757-64
references.pmid: 17452537