EMPAKT-CHF Study- DAC Process Example

The 2019 EMAPKT CHF study was a 50-patient observational study conducted in Germany at Charité Universitätsmedizin Berlin and Kerckhoff Klinik in Bad Nauheim. During the course of the study, patients had actual measurements of vascular blood volume and GFRs determined by FAST BioMedical’s technology at two points during the course of hospitalization for decompensated heart failure. The treating physicians were not given these measurements during the course of care. Upon the conclusion of the study, a Data Adjudication Committee (DAC) comprised of Peter McCullough, M.D., Maria Rosa Costanzo, M.D., and Michael Haase, M.D. reviewed each patient’s record and the course of treatment chosen by the treating physician. The DAC then considered whether the measurements of plasma volume, blood volume, and measured GFR all determined using FAST BioMedical’s technology would have caused them to change the patient’s course of treatment had this information been available during routine care.

In this video, DAC Chair Peter McCullough speaks to how FAST BioMedical’s measurements of vascular volume and GFR factored into the decisions made by the committee.

The FAST PV and mGFR Technology is an investigational product and is not approved for human use.