About the PRECEDE-HF Trial: Interview with William T. Abraham, MD, FACP, FACC, FAHA

Describe the PRECEDE-HF trial. What is the purpose of the trial? PRECEDE HF is the first large, randomized, controlled trial to evaluate the utility of implantable device-based monitoring technologies in heart failure. It has been designed and prospectively powered to determine if the use of standard clinical assessment plus Cardiac Compass with OptiVol Fluid Status monitoring improves outcome (reduces the combined endpoint of heart failure hospitalization and all-cause mortality) compared to standard clinical assessment alone. The study will be conducted at up to 100 centers in the United States and up to 15 centers in Canada to meet study enrollment needs in a timely manner. Up to 2,550 subjects will be enrolled. Enrollment will continue until either sufficient events to analyze the primary objectives have been obtained or the maximum amount of subjects has been enrolled. What are the start and end dates? The study began in the Fall of 2007. The duration of the study depends on enrollment and event rates. The study may last as long as five years, but it is likely to conclude sooner. As noted above, up to 2,550 subjects may be enrolled; however, the trial may end before this enrollment is complete, as it is an event-driven trial. This means that the trial ends when a critical number of total events (death from any cause or first heart failure hospitalization) occurs. Who is eligible to enroll in this trial? The trial is intended to recruit "real world" patients. Any adult heart failure patient who has a Medtronic device that includes Cardiac Compass with OptiVol Fluid Status monitoring and who has had an episode of worsening heart failure requiring intravenous treatment in the past 12 months is potentially eligible. Describe the Cardiac Compass with OptiVol Fluid Status Monitoring technology. How do these features work? What patient data do they help gather? Cardiac Compass with OptiVol Fluid Status monitoring measures several physiological parameters that may aid in the determination of a patient's clinical status. Such parameters include patient activity level, heart rate variability, and intrathoracic impedance (displayed as the OptiVol Fluid Index). In prior studies, decreases in these measures have been seen preceding hospitalizations for heart failure. This trial will determine if the knowledge of these measures can help keep patients alive and out of the hospital for longer periods of time. Is there any learning curve when using this technology? For clinicians, shared experience among many investigators should help mitigate any learning curve. What do you find promising about this technology? The promising aspect of this technology is that it may give us early warning to impending episodes of worsening heart failure well before symptoms occur, and therefore allow us to keep patients out of the hospital. How does the Cardiac Compass with OptiVol Fluid Status Monitoring differ from other remote monitoring products available today? Cardiac Compass with OptiVol Fluid Status monitoring is unique in that it is the only FDA-approved system for intrathoracic impedance monitoring. The total suite of diagnostics is also unique. How many heart failure related hospitalizations take place each year at your institution? We have about 1,000 heart failure hospitalizations each year at the Ohio State University Medical Center. Pending results of the PRECEDE-HF trial, how will the Cardiac Compass and OptiVol Fluid Status Monitoring technologies change the treatment and outlook of heart failure? Cardiac Compass with OptiVol Fluid Status monitoring has already changed the way we view heart failure. We now know that for many patients, their health can slowly worsen over many days to weeks. This is reflected in physiological changes that can be detected by Cardiac Compass with OptiVol Fluid Status monitoring and help us better manage our patients.