FLORENCE, Italy, May 22, 2016 /PRNewswire/-- ResMed (NYSE:
RMD) today announced primary results from a multicenter,
randomized controlled Phase II trial known as CAT-HF presented at
the European Society of Cardiology's 2016 Annual Heart Failure
Congress. CAT-HF assessed whether the treatment of moderate to
severe sleep-disordered breathing (obstructive or central sleep
apnea) with adaptive servo-ventilation (ASV) therapy could improve
cardiovascular outcomes in patients who were hospitalized for a
sudden worsening of their heart failure symptoms (acute
decompensated heart failure) over six months.
The results of the trial were presented as a late-breaking
presentation by Christopher M.
O'Connor, M.D., the principal investigator of the study and
Chief Executive Officer and Executive Director of the Inova Heart
and Vascular Institute.
Cardiovascular outcomes were defined in the trial by a Global
Rank Score primary endpoint that included survival free from
cardiovascular hospitalization and improvement in functional
capacity as measured by the six-minute walk distance.
The overall study results were neutral (based on a hazard ratio
[HR] =1.07, 95 percent confidence interval [95% CI] = (0.75, 1.51),
p-value = 0.717). However, a pre-specified subgroup analysis showed
a statistically significant improvement in the primary endpoint for
people with heart failure with preserved ejection fraction who have
sleep-disordered breathing (based on a HR = 0.38, 95% CI = (0.15,
0.98), p-value = 0.045).
"These results are important because they are the first to show
that addressing sleep-disordered breathing with ASV therapy may
improve cardiovascular outcomes for people with preserved ejection
fraction heart failure," said ResMed Chief Medical Officer,
Glenn Richards, M.D. "We look
forward to fully analyzing the results to better understand the
role of addressing sleep-disordered breathing in patients with
heart failure to determine who would be appropriate candidates for
ASV therapy."
Chronic heart failure occurs when the heart does not pump enough
blood to meet the needs of the body. When the heart contracts
normally but does not relax sufficiently to fill the chamber with
enough blood, it is classified as heart failure with preserved
ejection fraction. If the heart cannot contract to pump enough
blood, it is heart failure with reduced ejection fraction.
Approximately half of people with chronic heart failure have heart
failure with preserved ejection fraction.
CAT-HF is the second randomized controlled ResMed-sponsored
study examining the role of treating sleep-disordered breathing in
people with heart failure. Last year, results were published from a
Phase IV study known as SERVE-HF that showed ASV therapy should not
be used for patients with predominant central sleep apnea and
symptomatic chronic heart failure with reduced ejection
fraction.
CAT-HF was designed to address a different scientific question
of whether cardiovascular outcomes could be improved with ASV
therapy after hospitalization for sudden worsening symptoms for
people with both preserved and reduced heart failure who also have
either obstructive or central sleep apnea.
"There are no level of evidence 1A guideline recommended
therapies specific for heart failure with preserved ejection
fraction, which accounts for half of all people living with chronic
heart failure," O'Connor said. "These results from CAT-HF suggest
we need to study the role of whether addressing sleep-disordered
breathing can help people who have heart failure with preserved
ejection fraction."
ResMed is researching how addressing sleep-disordered breathing
may help people with cardiovascular diseases, from hypertension and
coronary artery disease, to heart failure, atrial fibrillation, and
stroke.
About Sleep-disordered Breathing
Sleep-disordered
breathing encompasses a spectrum of breathing problems during
sleep. The two most common types of sleep apnea, a condition that
results in repetitive pauses in breathing during sleep, are
obstructive sleep apnea and central sleep apnea.
Obstructive sleep apnea is a sleep disorder in which the throat
muscles relax, block the airways and stop the flow of breath during
sleep. Central sleep apnea is a sleep disorder in which the brain
does not transmit the "breathe" signal to the muscles that control
breathing during sleep. In either situation, the lack of oxygen
causes the person to wake up to catch their breath and start
breathing again, interrupting continuous sleep. This may occur
multiple times in an hour.
Sleep-disordered breathing is found more commonly in patients
with heart failure than it is in the general population, and people
with heart failure often report poor sleep as a symptom.
About CAT-HF
CAT-HF is a randomized controlled trial
that evaluated whether adding adaptive servo-ventilation (ASV) to
optimized medical therapy could improve cardiovascular outcomes at
six months for people with acute decompensated heart failure (HF)
patients compared to optimized medical therapy alone. Patients were
enrolled with a prior or new diagnosis of heart failure after
admission to the hospital with sudden worsening of heart failure
symptoms.
The primary endpoint was cardiovascular outcomes measured as a
Global Rank Score of six-minute walk distance, hospitalizations due
to cardiovascular issues and death. The study also assessed changes
in functional parameters, arrhythmias, biomarkers, quality of life
(QoL), and sleep and breathing.
About ResMed
ResMed (NYSE:RMD) changes lives with
award-winning medical devices and cutting-edge cloud-based software
applications that better diagnose, treat and manage sleep apnea,
chronic obstructive pulmonary disease (COPD) and other chronic
diseases. ResMed is a global leader in connected care, with more
than 1 million patients remotely monitored every day. Our
5,000-strong team is committed to creating the world's best
tech-driven medical device company – improving quality of life,
reducing the impact of chronic disease, and saving healthcare costs
in more than 100 countries.
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SOURCE ResMed Inc.