SAN FRANCISCO, Feb. 2 /PRNewswire/ -- The first-ever practical bedside
tool with the potential to predict high, intermediate and low risk of death in
hospitalized heart failure patients was published today in the Journal of the
American Medical Association. The new tool, identified by investigators from
the world's largest heart failure registry known as ADHERE(R) (Acute
Decompensated Heart Failure National Registry), was derived from an
observational evaluation of 39 clinical variables from more than 65,000
patients hospitalized with heart failure. It shows that the risk of
in-hospital death can be easily predicted in these patients using the results
of two simple blood tests and a single blood pressure measurement.
According to the American Heart Association, heart failure is a serious
condition that affects nearly 5 million Americans, with 550,000 new cases each
year. It is the most frequent cause of hospitalization in patients over 65
years of age.
Heart failure occurs when the heart muscle becomes weakened or damaged and
lacks the strength to pump enough blood to meet the body's needs. A heart
failure patient whose condition suddenly or rapidly deteriorates may be
described as "acutely decompensated" with symptoms that warrant care in a
hospital or acute care setting.
Assessing a patient's risk of death upon hospital admission has been shown
to help guide medical decision making and outcomes for patients with acute
coronary syndromes such as heart attack and unpredictable bouts of chest pain.
Such assessments can help clinicians determine which patients need to be
treated in a more closely monitored setting and may be helpful in designing
clinical trials where risk is balanced across treatment groups or only
patients of specific mortality risk are enrolled. Until now, useful risk
assessment tools for acutely decompensated heart failure (ADHF) patients did
not exist.
Using a type of statistical analysis known as CART (Classification And
Regression Tree), ADHERE(R) study investigators analyzed a multitude of
clinical variables to develop a tool to assess mortality risk in heart failure
patients. They were able to define three clinical characteristics that put
hospitalized heart failure patients at greatest risk of mortality. The three
characteristics: high levels of blood urea nitrogen (BUN greater than or equal
to 43 mg/dL), a measurement of kidney function; low systolic blood pressure
(SBP <115 mm Hg), a measure of pressure in the arteries when the heart
contracts; and high serum creatinine (Cr greater than or equal to 2.75 mg/dL),
another measure of kidney function, were also used to accurately predict high,
low and intermediate risks of mortality. The validity of the tool was then
tested using data from additional hospitalizations.
The overall mortality risk for patients hospitalized with acute heart
failure was 4.1 percent. The tool determined mortality risk levels starting
from low risk at 2.1 percent, up to 21.9 percent for patients at the highest
mortality risk.
"This new tool is a first for the treatment of acute decompensated heart
failure, and offers a simple quick way for clinicians to assess mortality risk
upon hospital admission and rapidly decide on a treatment strategy," said lead
study investigator, Gregg C. Fonarow, MD, Director of the Ahmanson-UCLA
Cardiomyopathy Center and Professor of Medicine in the Division of Cardiology
at the University of California, Los Angeles. "The continued high mortality
rate for patients hospitalized with acute decompensated heart failure provides
a compelling indication to apply tools that may lead to improved evaluation,
management, and potential outcomes in these patients."
"Implemented on a wide-scale across our nation's hospitals, cardiologists,
hospitalists and primary care physicians involved in the care of patients with
heart failure will be able to use this simple tool to assess mortality risk in
these patients. The potential impact on better resource utilization and
improved outcomes for Americans with heart failure is substantial," said
contributing investigator, Clyde W. Yancy, M.D., Professor of Medicine and
Cardiology, and Director of the Congestive Heart Failure/Heart Transplant
Program at the University of Texas Southwestern Medical Center in Dallas.
"This is a significant first step towards reducing in-hospital mortality for
heart failure."
About the ADHERE(R) Observational Analysis
This ADHERE study is an analysis of 65,275 cases of patients hospitalized
with a primary diagnosis of acutely decompensated heart failure from 263
hospitals across the U.S. between October 2001 and July 2003.
To determine the best predictors of in-hospital mortality, ADHERE(R)
investigators used CART (Classification And Regression Tree) statistical
analysis to evaluate 39 clinical variables including demographics, medical
history, laboratory tests and vital signs from 33,046 heart failure
hospitalizations between October 2001 and February 2003.
Based on this initial evaluation, investigators created a decision tree
that graphically represented the best predictors of in-hospital mortality in
these patients. To validate the model, investigators tested the ability of the
decision tree to accurately predict mortality in 32,229 subsequent
hospitalizations of heart failure patients between March and July 2003.
Additional variables to identify mortality risk beyond high BUN, low SBP
and high serum Cr were identified but did not add sufficient discrimination to
merit inclusion into the decision tree. By identifying two measures of kidney
function as primary predictors of in-hospital mortality in heart failure
patients, investigators raised the importance of monitoring renal function in
these patients.
About ADHERE(R)
The ADHERE(R) registry is a first-of-its-kind national registry that
collects observational data from across the U.S. in order to track and study
the clinical characteristics and medical management of patients hospitalized
with acute heart failure. ADHERE(R) is designed to help the medical community
better understand acute heart failure, improve its management and enhance
quality of care. The ADHERE(R) national registry is sponsored by Scios Inc.
and overseen by an independent scientific advisory committee of nationally
recognized heart failure experts.
To learn more about the ADHERE(R) registry, call 1-866-616-2993, visit
http://www.adhereregistry.com or e-mail adhereinfo@sciosinc.com.
About Heart Failure
Heart failure is not a heart attack and does not mean the heart has
stopped working. Heart failure is typically a chronic and progressive
condition that, if detected and treated early in the disease process, may be
effectively managed.
Heart failure symptoms may include shortness of breath; swelling of the
ankles, legs, feet, abdomen, or lower back; weakness or tiredness; coughing
when lying down; sudden increases or decreases in weight; sleep disturbances;
difficulty concentrating or impaired thinking; and changes in eating habits.
About Scios Inc.
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company
headquartered in Fremont, California. Scios is developing novel treatments for
cardiovascular disease, inflammatory disease and cancer. The Company's
disease-based technology platform integrates expertise in protein biology with
computational and medicinal chemistry to identify novel targets and rationally
design small molecule compounds and peptides for markets with unmet medical
needs. For more information, visit http://www.sciosinc.com.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Chris B. Ernst of Scios Inc.,
+1-415-710-9445; or Karin Bauer Aranaz of WeissComm Partners,
+1-415-859-3414, for Scios Inc.
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