Cardiac Biomarker Soluble ST2 Shows Significant Clinical Value Over Natriuretic Peptide Markers In Monitoring Hospitalized Heart Failure Patients

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease
Article Date: 25 Nov 2008 - 9:00 PDT

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Critical Diagnostics announced today the publication of a key research paper identifying the clinical value of the cardiac biomarker soluble ST2 (sST2) as a tool to monitor patients hospitalized for heart failure.

The research paper, "Serial Sampling of ST2 Predicts 90-day Mortality Following Destabilized Heart Failure" was published in the current issue of Journal of Cardiac Failure . The results described in this research paper provide objective evidence that monitoring sST2 concentrations during hospitalization aids in stratifying patients according to their predicted mortality and may further assist in guiding treatment.

"Although considerable effort and resources have been invested in evaluating the available tools, such as BNP and NT-proBNP, for utility in monitoring therapeutic effectiveness, the results have been disappointing," says Critical Diagnostics President James V. Snider, Ph.D. "Objectively evaluating effectiveness of patient care remains very difficult for the treating physician. The research described in this paper identifies that sST2 concentrations provide the desired capability to provide guidance for therapeutic effectiveness as well as for outpatient treatment strategy."

The study analyzed a cohort of 150 patients hospitalized with acutely destabilized heart failure at the Veteran Affairs Healthcare System in San Diego, CA. Multiple cardiac-related parameters were measured including sST2, BNP, NT-proBNP, and blood urea nitrogen (BUN) in plasma samples collected at six time points between admission and discharge. This analysis showed that the change in sST2 concentrations during hospitalization and treatment for acutely destabilized heart failure is powerfully and independently predictive of 90 day mortality risk. It also identifies the potential utility of sST2 to monitor treatment effectiveness and to provide guidance in transitioning patients to outpatient management. Cardiology principal investigator and author on this paper, Dr. Alan S. Maisel, Professor of Medicine at the University of California, San Diego as well as the Director of the Coronary Care Unit and Heart Failure Program at the VA Medical Center in La Jolla added, "ST2 gives prognostic information above and beyond natriuretic peptide measurements. This suggests that both neurohormonal and immunological/inflammatory dysregulation are active in the patient with decompensated heart failure."

The incidence of heart failure in the US is increasing resulting in greater healthcare expenditures and creating demand for better tools to more effectively manage patient care. The results reported in this paper show that sST2 concentrations change within days of hospital admission and that the change in concentration is powerfully prognostic. "Clearly there is a need for a biomarker whose change during therapy predicts outcome. This publication is the first to show changes in sST2 predict 90 day mortality." comments paper senior author Robert L. Fitzgerald, Ph.D, who is an Associate Professor of Pathology at University of California San Diego and is the Associate Director of Clinical Chemistry at the VA Medical Center in San Diego.

About Critical Diagnostics

Critical Diagnostics is the exclusive developer of the Presage™ laboratory assays employing sST2 for risk stratification, patient monitoring, and therapy guidance of patients with cardiovascular disease1.

1Presage and assays employing ST2 are not currently approved by the FDA for clinical use and are not available for sale in the US for clinical use.

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