FAST BioMedical (FAST), a privately held late clinical-stage medical technology company, today announces the European Society of Cardiology (ESC) Heart Failure Journal has published additional results from its fourth human clinical trial. The published data indicate that estimated surrogate measurements for decongestion are not reflective of actual plasma volume status in hospitalized patients with acute heart failure.
The Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure (EMPAKT CHF) clinical trial was an observational study conducted at Charité Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim in Germany. Thirty-six heart failure patients were assessed for measured plasma volume, measured red cell volume, and total blood volume using FAST Technology at two-time points 48 hours apart during the course of diuretic therapy. It has been suggested that changes of venous hemoglobin concentrations and hematocrit are surrogate measurements of decongestion. The objective of this study was to assess the relationship of changes of measured plasma volume with changes in hemoglobin and hematocrit in patients with acute heart failure.
As reported in the ESC Heart Failure publication, changes of hemoglobin or hematocrit in many patients were not reflective of directly measured changes of intravascular volume status in acute heart failure patients. This suggests that basing clinical assessments of decongestion on changes of hemoglobin concentrations of hematocrits may misguide clinical decision-making on an individual patient level.
“Clinicians often consider changes of hemoglobin or hematocrit as an indicator of acute alterations of intravascular volume status. However, hemoglobin and hematocrit are affected by other factors, for instance by blood loss, transfusions or redistribution of red blood cell pools to remote vascular beds. This may be particularly relevant in patients hospitalized for acute heart failure. The data from the EMPAKT CHF study suggest that the changes of hemoglobin and hematocrit provide an inadequate assessment of actual changes of plasma volume in acute heart failure,” said first author Dr. Jutta Swolinsky from the Department of Nephrology and Medical Intensive Care at Charité Universitätsmedizin Berlin.
“This is of interest because clinical decisions are often based on the presumed changes of a patient’s intravascular volume status. For instance, an increase of hematocrit is often viewed as evidence of successful decongestion in patients with acute heart failure, but our study indicates that this notion may often be misleading,” added Principal Investigator Prof. Kai Schmidt-Ott, also from the Department of Nephrology and Medical Intensive Care at Charité Universitätsmedizin Berlin.
ESC Heart Failure is the open-access journal of the Heart Failure Association that improves the understanding, prevention, investigation, and treatment of heart failure. ESC Heart Failure also published a first study using EMPAKT CHF trial data in April 2021 that suggested current standards of care are inadequate for assessing both kidney function and changes in kidney function in hospitalized patients with acute decompensated heart failure.
FAST BioMedical has conducted four human clinical studies including 147 patients in Europe and the United States. All studies met their primary end-points which were targeted at the safety and performance of the FAST Technology across a variety of patients, function levels, and disease states. The trials have generated data demonstrating a favorable safety profile, as well as the ability to determine volume status and kidney function in the populations studied.
FAST‘s first-in-class technology aims to revolutionize treatment for heart failure patients by providing easy, rapid, accurate, quantitative, and simultaneous measurements of intravascular volume and measured glomerular filtration rate in clinically actionable timeframes.