FAST BioMedical has announced the publication of additional results from the EMPAKT CHF (Estimating versus Measuring Plasma Volume and Kidney Function in Acute Decompensated Congestive Heart Failure) clinical trial in the European Society of Cardiology (ESC) Heart Failure journal. The published data indicate that estimated surrogate measurements for decongestion are not reflective of actual plasma volume status in hospitalised patients with acute heart failure.
The 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 haemoglobin concentrations and haematocrit are surrogate measurements of decongestion. The objective of this study was to assess the relationship of changes of measured plasma volume with changes of haemoglobin and haematocrit in patients with acute heart failure.
As reported in the publication, changes of haemoglobin or haematocrit 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 haemoglobin concentrations of haematocrits may misguide clinical decision making on an individual patient level.
“Clinicians often consider changes of haemoglobin or haematocrit as an indicator of acute alterations of intravascular volume status. However, haemoglobin and haematocrit 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 hospitalised for acute heart failure. The data from the EMPAKT CHF study suggest that the changes of haemoglobin and haematocrit provide an inadequate assessment of actual changes of plasma volume in acute heart failure,” said first author 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 haematocrit 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 Kai Schmidt-Ott, also from the Department of Nephrology and Medical Intensive Care at Charité Universitätsmedizin Berlin.
FAST BioMedical has conducted four human clinical studies including 147 patients in Europe and the USA. All studies met their primary endpoints which were targeted at the safety and performance of the FAST Technology across a variety of patients, function levels and disease states.
FAST‘s technology aims to provide easy, rapid, accurate, quantitative and simultaneous measurements of intravascular volume and measured glomerular filtration rate in clinically actionable timeframes, the company said in a press release.