FAST BioMedical Announces Successful Completion of Multi-center Acute Congestive Heart Failure Trial in Germany
INDIANAPOLIS and BERLIN and BAD NAUHEIM, Germany, Jan. 9, 2020 /PRNewswire/ -- FAST BioMedical announced the completion of the EMPAKT-CHF clinical trial at Charité – Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim. The trial evaluated the impact of FAST BioMedical’s Blood Volume and Kidney Function measurement technology in patients with acute congestive heart failure and cardiorenal syndrome. This observational study was designed to demonstrate how repeated measurements of blood volume and kidney function could change clinical decision making and ultimately improve the management of heart failure patients.
It is estimated that there are 26 million people with heart failure worldwide, and for patients with acute congestive heart failure, abnormal blood volume levels have been directly linked to kidney failure, worsening outcomes, and increased mortality.
As the first technology capable of directly measuring blood volume, changes in blood volume and kidney function, FAST BioMedical’s metrics could be a significant advancement for managing volume and volume-related kidney injury in patients with acute congestive heart failure.
“The EMPAKT CHF study explored the need for better technology to assess the complex relationships between blood volume, kidney function, and diuretic therapy in patients with acute congestive heart failure. Clinical assessment is the Achille’s heel in managing this patient population, and we believe this study will help establish that quantitative assessments of blood volume and kidney function would better inform physician decision making” said Peter McCullough, MD, MPH, who served as head of the independent data adjudication committee for the EMPAKT CHF Study.
About FAST BioMedical
FAST BioMedical is a privately held, late clinical-stage medical technology company based in Indianapolis, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way. This has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.
SOURCE FAST BioMedical