Source: Annual Congress 2008 - Outcome of adaptive servo ventilation in sleep apnoea
Disease area: Pulmonary vascular diseases, Sleep and breathing disorders

Abstract

Objective: The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure (HF) due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central.
Study Design: Randomised, multi-centre, international trial with parallel group design, with patients randomised to either control (optimal medical management) or active treatment (optimal medical treatment plus use of adaptive servoventilation) in a 1:1 ratio. Assumptions: the intervention reduces the hazard rate by 20%. The event rate in the control group is 35% in the first year. The trial is an event driven design.
Number of Patients: 1260 patients will be randomly assigned to one of the two treatment groups. A 20% drop out rate is estimated.
Selection criteria: Patients at the age of or over 18 years with severe chronic HF, NYHA III-IV or NYHA class II with at least one hospitalisation for HF within the last 12 months, with LVEF <40% and SDB (AHI > 15/h) with 50% central events and a central AHI ≥ 10/h, no change of medication and no hospitalization for more than 1 month before randomization and medical therapy according to the applicable guidelines
Primary Endpoints
Time to first event of:
1) all cause mortality or unplanned hospitalization for worsening heart failure
2) cardiovascular mortality or unplanned hospitalization for worsening heart failure.
3) all cause mortality or all cause hospitalization.

Rating:

Share or cite this content

Citations should be made in the following way:
M. Cowie (Co-PI), T. Helmut (Co-PI), SERVE-HF-Steering Committee Members Prof. Martin Cowie; Prof. Erland Erdmann; Prof. Patrick Levy... (London, United Kingdom; Essen, Martinsried, Germany). The design of the Serve-HF study: treatment of sleep-disordered breathing with predominant central sleep apnoea by adaptive servo ventilation in patients with heart failure. Eur Respir J 2008; 32: Suppl. 52, 4217

Member's Comments

No comment yet.

Related content which might interest you: Auto servo–ventilation in patients with obstructive sleep apnea syndrome and periodic breathing – a pilot study Source: Annual Congress 2007 - Sleep apnoea and adaptive servo–ventilation Year: 2007 Home respiratory polygraphy for diagnosis of sleep-disordered breathing in heart failure Source: Eur Respir J 2004; 24: 443-448 Year: 2004 Effect of vadaptive servo ventilation on mortality in patients with systolic heart failure and central sleep apnea Source: International Congress 2017 – Obstructive and central sleep apnoea: consequences and comorbidities Year: 2017 Adaptive servo ventilation in the treatment of central sleep apnea related to ischemic stroke Source: Annual Congress 2012 - Physiology, obesity and the downstream effects of OSA Year: 2012 Ventilatory support and pharmacological treatment of patients with central apnoea or hypoventilation during sleep Source: Eur Respir Rev 2007; 16: 115-124 Year: 2007 Assisted ventilation for heart failure patients with Cheyne-Stokes respiration Source: Eur Respir J 2002; 20: 934-941 Year: 2002 Shift in sleep apnoea type in heart failure patients in the CANPAP trial Source: Eur Respir J 2010; 35: 592-597 Year: 2010 Eficacy of the treatment with CPAP in patients with chronic heart failure and sleep apnoea Source: Eur Respir J 2004; 24: Suppl. 48, 564s Year: 2004 Treatment of obstructive and central sleep apnoea in heart failure: current concepts and perspectives Source: Annual Congress 2005 - PG12 - Sleep-related problems: treatment of obstructive sleep apnoea - current concepts and perspectives Year: 2005 Sleep apnea in patients with heart failure effectiveness of continuous positive airway pressure Source: Annual Congress 2008 - Weight control and comorbidity in obstructive sleep apnoea Year: 2008 Time course of CPAP effects on central sleep apnoea in chronic heart failure Source: Breathe 2009; 5: 355 Year: 2009 Management of central sleep apnoea (CSA) by adaptative servo ventilation Source: Eur Respir J 2005; 26: Suppl. 49, 114s Year: 2005 Respiratory mechanics study; breathing pathern; and sleep study in patients with congestive heart failure and nocturnal cheyne-stokes respiration Source: Eur Respir J 2003; 22: Suppl. 45, 465s Year: 2003 Effects of adaptive servoventilation on sleep quality in treatment emergent central sleep apnea and central sleep apnea in heart failure patients with preserved ejection fraction Source: International Congress 2017 – CPAP therapy Year: 2017 Inspiratory duty cycle responses to flow limitation predict nocturnal hypoventilation Source: Eur Respir J 2009; 33: 1068-1076 Year: 2009 Sleep-disordered breathing in patients with heart failure: a theoretical study Source: Eur Respir J 2005; 26: Suppl. 49, 358s Year: 2005 Noninvasive pressure preset ventilation for the treatment of Cheyne-Stokes respiration during sleep Source: Eur Respir J 2001; 17: 1250-1257 Year: 2001 Coexistence of central sleep apnea or periodic breathing pattern in patients with congestive heart failure and obstructive sleep apnea Source: Annual Congress 2012 - CPAP: beneficial effects on different aspects of health Year: 2012 CPAP versus adaptive servoventilator (ASV) in patient with congestive heart failure and sleep disorder breathing Source: Annual Congress 2012 - Physiology, heart failure and respiration in relation to OSA Year: 2012 Evaluation of a new algorithm for patients with cheyne-stokes breathing and obstructive sleep apnea Source: Annual Congress 2007 - Sleep apnoea and adaptive servo–ventilation Year: 2007