ResMed Announces First Major Study To Investigate How Breathing Difficulties During Sleep Affect Heart Failure Patients

Main Category: Respiratory / Asthma
Also Included In: Cardiovascular / Cardiology
Article Date: 06 Oct 2008 - 4:00 PDT

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ResMed today announced it has launched the SERVE-HF study at the 18th European Respiratory Society's (ERS) annual congress in Berlin, Germany. The study is to investigate the use of its AutoSet CS™2 device in the treatment of sleep-disordered breathing that affects patients with chronic heart failure.

The international SERVE-HF study, the largest of its kind, will focus specifically on the impact of treatment of central sleep apnoea (CSA) in patients with heart failure. Up to 76 percent of patients with heart failure also suffer from sleep-disordered breathing, in which normal breathing during sleep is interrupted. Around two thirds of those patients with clinically significant sleep-disordered breathing have CSA. It is characterised by periods of shallower breathing, known as hypopnoea, as well as periods when breathing is halted altogether, known as apnoea. The respiratory changes are caused by a disorder of respiratory control mechanisms, different from obstructive sleep apnoea (OSA), where the respiratory events are caused by an increased collapsibility of the upper airway.

During the four year SERVE-HF study, physicians will examine the long-term benefits and the costeffectiveness of the breathing support provided by the AutoSet CSTM2 for the treatment of heart failure patients.

The AutoSet CSTM2 is an intuitive ventilator that monitors breathing constantly throughout the night. In a process known as adaptive servo-ventilation, it takes into consideration breathing rate and the amount of air inhaled and exhaled. When the device detects any changes in either of these factors, it helps maintain normal breathing.

It is anticipated that the study, funded by ResMed, will help physicians to better understand how heart failure progression can be reduced during treatment with adaptive servo-ventilation. It will also provide researchers with valuable information on the effect of heart failure on key factors such as hospitalisation, quality of life, and the ability to exercise.

"The SERVE-HF study is designed to give clinicians the important information they need to better manage the significant number of heart failure patients who experience sleep-disordered breathing," said Professor Helmut Teschler, Medical Director at the Department of Pneumology, Ruhrland Clinic, Essen. "The contribution of the AutoSet CS 2 device in the management of such disorders will also become much clearer."

The researchers plan to recruit 1260 heart failure patients at 80 clinics across Germany, France, UK, Norway, Sweden, Denmark and the USA. Sleep-related breathing disorders such as sleep apnoea are very common, affecting approximately 5 percent of women and 10 percent of men between the age of 20 and 60. However, up to 95 percent of those suffering from sleep apnoea have not been diagnosed and treated for their condition. People with this breathing disorder are at increased risk of developing high blood pressure (hypertension) and stroke, as well as heart failure.

Effective treatment of breathing problems such as sleep-disordered breathing is important to ensure that patients' sleep is healthy and uninterrupted. Additionally, typical symptoms such as fatigue and daytime tiredness disappear and patients also notice a significant improvement in their quality of life.

About ResMed

ResMed is a leading manufacturer of medical equipment for the treatment and management of sleep-disordered breathing and other respiratory disorders. ResMed is dedicated to developing innovative products to improve the lives of those who suffer from these conditions and to increasing awareness among patients and healthcare professionals for the potentially serious health consequences of untreated sleep-disordered breathing.

ResMed