New Publication Highlights Transient Increases in Creatinine or Tubular Injury Markers in Heart Failure Patients Should Not D...
August 08 2019 - 7:00AM
CHF Solutions, Inc. (Nasdaq: CHFS) announced today the
publication of a study in Circulation Heart Failure1 highlighting
the benefits of decongestion outweigh concerns from previous
studies that showed a rise in creatinine levels or tubular injury
markers.
The study, titled, “Renal Effects of Intensive Volume Removal in
Heart Failure Patients With Preexisting Worsening Renal Function”
further analyzed data on renal tubular injury biomarkers from a
subset of 105 participants in the CARRESS-HF trial. The study
supports that increases in serum creatinine should not be the major
factor to dissuade decongestion by ultrafiltration or diuretics in
patients where a therapeutic advantage may exist. Even if
creatinine worsened and tubular biomarkers increased, renal
function usually recovered by 60 days. In fact, participants with
an increase in urinary biomarkers (who had 12-fold-increase odds of
worsening renal function defined by a 20% change in serum
creatinine) had the greatest improvement in kidney function at 60
days. Thus, changes in serum creatinine or kidney injury biomarkers
should be discouraged as a surrogate endpoint in heart failure
trials. Study authors concluded that modest or transient
increases in creatinine levels, or increases in renal tubule injury
biomarkers were outweighed by the benefits of decongestion, which
aligns with the review conducted by Drs. Costanzo and Kazory
published in the European Journal of Heart Failure, which stated,
“It follows that the foremost aim of therapy to improve outcomes of
fluid overloaded heart failure patients must be to achieve
effective decongestion.” 2 This study showed no evidence that
ultrafiltration is inferior for decongestion or worse
post-discharge clinical outcomes.
“In the past, we have received some criticism regarding the
increase in creatinine levels with ultrafiltration, such as with
the Aquadex FlexFlow® system, and our response has been that the
ultimate benefits outweighed potential risks. This analysis
is yet another study that supports this assertion, with the added
information that increases in serum creatinine levels were
associated with superior decongestion and recovery of renal
function at 60-days even in the presence of renal tubing injury
biomarkers,” commented John Erb, chairman and chief executive
officer of CHF Solutions. "This study is further validation
of our long-held position that ultrafiltration therapy has the
potential to significantly improve outcomes in heart failure
patients, with the added advantages of reducing rehospitalizations
and providing less impact on the healthcare system as a
whole. We are very proud of our technology and are pleased to
share this data with medical professionals interested in maximizing
patient outcomes in the heart failure setting.”
About CHF Solutions
CHF Solutions, Inc. (NASDAQ:CHFS) is a medical device company
focused on developing, manufacturing and commercializing the
Aquadex FlexFlow system for aquapheresis therapy. The Aquadex
FlexFlow system is a clinically proven therapy that provides a
safe, effective and predictable method of removing excess sodium
and fluid from patients suffering from fluid overload. The Aquadex
FlexFlow system is indicated for temporary (up to eight hours)
ultrafiltration treatment of patients with fluid overload who have
failed diuretic therapy and extended (longer than 8 hours)
ultrafiltration treatment of patients with fluid overload who have
failed diuretic therapy and require hospitalization. All treatments
must be administered by a healthcare provider, under physician
prescription, both of whom having received training in
extracorporeal therapies. The company's vision is to improve the
lives of fluid overloaded patients through science, collaboration,
and innovative medical technology. CHF Solutions is a Delaware
corporation headquartered in Minneapolis, Minnesota with wholly
owned subsidiaries in Australia and Ireland. The company has been
listed on the Nasdaq Capital Market since February 2012.
Forward-Looking Statements
Certain statements in this release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, including without limitation, statements
regarding the clinical performance of the Aquadex FlexFlow system.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Many factors could cause actual future events to
differ materially from the forward-looking statements in this
release, including, without limitation, those risk associated with
our ability to execute on our commercialization strategy, the
possibility that we may be unable to raise sufficient funds
necessary for our anticipated operations, our post-market clinical
data collection activities, benefits of our products to patients,
our expectations with respect to product development and
commercialization efforts, our ability to increase market and
physician acceptance of our products, potentially competitive
product offerings, intellectual property protection, our ability to
integrate acquired businesses, our expectations regarding
anticipated synergies with and benefits from acquired businesses,
and other risks and uncertainties described in our filings with
the SEC. Forward-looking statements speak only as of the date
when made. CHF Solutions does not assume any obligation
to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or
otherwise.
1 https://www.ncbi.nlm.nih.gov/pubmed/31163974
2 https://www.ncbi.nlm.nih.gov/pubmed/29671929
CONTACTS:
INVESTORS:
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
952-345-4205
ir@chf-solutions.com
-or-
Bret Shapiro
Managing Partner
CORE IR
516-222-2560
brets@coreir.com
www.coreir.com
MEDIA
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com
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