POWAY, Calif.--ResMed said last week it has launched an international study to investigate the impact of central sleep apnea treatment on patients with heart failure.
Announced at the 18th European Respiratory Society’s annual congress in Berlin, the SERVE-HF study is the largest of its kind, the company said. During the four-year study, physicians will examine the long-term benefits and cost-effectiveness of the breathing support provided by ResMed’s AutoSet CSTM2 for the treatment of patients with chronic heart failure.
Up to 76 percent of patients with heart failure also suffer from sleep-disordered breathing, and about two-thirds of those patients have CSA, according to a ResMed release. CSA is characterized by periods of shallower breathing, known as hypopnea, as well as periods when breathing is halted altogether, known as apnea. The respiratory changes are caused by a disorder of respiratory control mechanisms, different from obstructive sleep apnea, where the respiratory events are caused by an increased collapsibility of the upper airway, the company explained.
ResMed’s AutoSet CSTM2 is a ventilator that monitors breathing and, in a process known as adaptive servo-ventilation, 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.
“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, Germany. "The contribution of the AutoSet CS 2 device in the management of such disorders will also become much clearer."
The researchers plan to recruit 1,260 heart failure patients at 80 clinics across Germany, France, the United Kingdom, Norway, Sweden, Denmark and the United States.
Sleep-related breathing disorders affect approximately 5 percent of women and 10 percent of men between the ages of 20 and 60, ResMed said. However, up to 95 percent of those with sleep apnea have not been diagnosed and treated for their condition.
The study will also provide researchers with information on the effect of heart failure on key factors such as hospitalization, quality of life and the ability to exercise, according to the release.