SAN DIEGO, March 20, 2017 /PRNewswire/ -- ResMed (NYSE:RMD)
today announced publication of a study in the Journal of the
American College of Cardiology (JACC), which investigated
whether 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 (acute decompensated heart failure) over six
months.*
"Cardiovascular Outcomes With Minute Ventilation-Targeted
Adaptive Servo-Ventilation Therapy in Heart Failure – The CAT-HF
Trial" is a multicenter, randomized, controlled Phase II trial
funded by ResMed to broaden the understanding of how best to treat
diagnosed sleep apnea in patients that also have a particular form
of heart failure.
The overall study results were neutral (Wilcoxon p-value =
0.717). However, the study revealed a pre-specified subgroup
analysis that showed a statistically significant improvement in the
primary endpoint for people with moderate to severe
sleep-disordered breathing and heart failure with preserved
ejection fraction (HFpEF) (Cox p-value = 0.036). The primary
endpoint was cardiovascular outcomes measured as a Global Rank
Score that included survival free from cardiovascular
hospitalization and change in functional capacity as measured by
the six-minute walk distance. The study also assessed changes in
functional parameters, arrhythmias, biomarkers, quality of life
(QoL), and sleep and breathing.
Leading cardiologists say the improvement for HFpEF patients
with sleep apnea signals a potential breakthrough in treatment
options for those patients, and call for more research to be
done.
"There are no level of evidence 1A guideline recommended
therapies specific for HFpEF patients, which accounts for half of
all people living with chronic heart failure," said Christopher M. O'Connor, MD, the study's lead
investigator, cardiologist and CEO of the Inova Heart and Vascular
Institute. "These results from CAT-HF suggest we need to further
study the role of whether addressing sleep-disordered breathing can
help people who have heart failure with preserved ejection
fraction."
"This is another great step forward in understanding the
connection between sleep-disordered breathing, heart failure and
proper treatment methods," said Dr. Tony
DeMaria, a cardiologist from the University of California – San Diego. "We are looking forward to what
future heart failure research can tell us about key links to other
conditions our patients face."
"Having JACC publish this research is incredibly positive,
encouraging others to look deeper into the potential benefits of
ASV therapy," said Dr. Carlos Nunez,
ResMed Chief Medical Officer. "I hope future studies can further
establish these benefits and lead to life-improving treatment
recommendations for countless patients with sleep apnea."
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.
About chronic heart failure
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.**
An estimated 26 million people worldwide have heart
failure,1 split roughly half-and-half between those with
preserved vs. reduced ejection fraction.2 It is believed
that sleep-disordered breathing may be found in 69 percent of
patients with heart failure with preserved ejection fraction
(HFpEF),3 far more commonly than in the general
population. People with heart failure often report poor sleep as a
symptom.
About the CAT-HF study
The paper was based on the
CAT-HF trial, first presented at the European Heart Failure
conference in Italy in 2016.
CAT-HF was designed to address whether cardiovascular outcomes
could be improved with adaptive servo-ventilation (ASV) therapy for
either obstructive or central sleep apnea after hospitalization for
sudden worsening symptoms for people with both preserved and
reduced heart failure.
CAT-HF is a randomized controlled trial that evaluated whether
adding 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.
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 2 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.
ResMed.com | Facebook | Twitter | LinkedIn
* The AirCurve 10 ASV device is indicated for the treatment of
patients weighing more than 66 lb (30kg) with obstructive sleep
apnea (OSA), central and/or mixed apneas, or periodic
breathing.
** ASV therapy is contraindicated in patients with chronic,
symptomatic heart failure (NYHA 2-4) with reduced left ventricular
ejection fraction (LVEF ≤ 45%) and moderate to severe predominant
central sleep apnea. All patients diagnosed with sleep apnea should
consult with their physician to determine the most appropriate
treatment for their sleep apnea.
1 Ambrosy PA et al. JACC 2014
2 Givertz MM et al. Am J Cardiol 2001
3 Bitter T et al. Eur J Heart Fail 2009
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