Carmel, IN. and BERLIN –- May 1, 2019 – FAST BioMedical has enrolled 20 patients in a clinical trial at Charité – Universitätsmedizin Berlin. The trial is investigating the impact of FAST’s technology in patients with Acute Heart Failure and Cardiorenal Syndrome. This observational study will be a significant step towards understanding how repeated measurements of blood volume and kidney function can change clinical decision making and ultimately improve management of heart failure patients.
An estimated 26 million people have heart failure worldwide, and for patients with acute decompensated heart failure, abnormal blood volume levels are directly linked to kidney failure, worsening outcomes, and increased mortality.
The trial is named EMPAKT CHF which stands for Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure.
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 patients with acute decompensated heart failure.
“The EMPAKT CHF study will allow us to reexamine how we evaluate patients with acute decompensated heart failure. It will help us to assess the potential of guiding treatment with quantitative metrics as opposed to subjective evaluation,” said Professor Kai Schmidt-Ott, the study’s principal investigator at the Berlin-based university hospital Charité.
“This new technology could enable us to quantify and follow blood volume and kidney function in complex heart failure patients, including those patients at risk of developing cardiorenal syndrome,” said Dr. W, Frank Peacock, MD, FACEP, FACC, FESC and Associate Chief of Emergency Medicine Research at Baylor College of Medicine. “Being able to monitor real time blood volume and mGFR could allow us to optimize volume management to the individual patient and allow better treatment in this volatile population.”
The trial intends to enroll 50 patients total and to conclude in 2019.
About FAST BioMedical
FAST BioMedical is a privately held, late clinical-stage medical technology company based in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way. This has impact potential for 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.
For more information visit www.FASTBioMedical.com.