CINCINNATI—A multidisciplinary group of University of Cincinnati researchers is conducting a clinical trial to determine if an implantable device can identify undetected heart rhythm abnormalities in hemodialysis patients—a patient population at high risk for sudden cardiac death.
The study could also identify a link between heart rhythm abnormalities and a variety of electrolyte levels in the patients’ blood and in the solution used during the dialysis process, allowing for the development of interventions to address this issue.
"End-stage renal disease affects over 570,000 patients in the United States and approximately 2 million patients worldwide,” says Prabir Roy-Chaudhury, MD, PhD, professor in the division of nephrology and hypertension at the UC College of Medicine and the principal investigator on the study. "While kidney transplantation is the most effective means of treatment, only 20 to 30 percent of these patients receive one; therefore, a significant proportion of patients rely on dialysis to replace kidney function.”
Hemodialysis is a technique in which a machine filters wastes out of a patient’s blood once the kidney fails.
Roy-Chaudhury, a UC Health nephrologist, who is conducting the study in close collaboration with Alexandru Costea, MD, associate professor in the division of cardiovascular diseases at UC and a UC Health electrophysiologist, says dialysis patients have high hospitalization rates, high mortality and low five-year survival rates. Additionally, large shifts in electrolytes and volume during the thrice-weekly dialysis sessions combined with underlying structural and functional cardiovascular disease increase patient risk for arrhythmias, cardiac arrest and sudden cardiac death.
"In fact, sudden cardiac death occurs up to four times more frequently in end-stage kidney disease patients than in the general population,” he adds. "Little is known about the frequency of arrhythmias and how they relate to the patient’s volume and electrolyte status, dialysis session patterns or how they manifest to cause sudden cardiac death.
"In this study, we hope to characterize and estimate the occurrence of arrhythmic events in hemodialysis patients through extended cardiac monitoring using Medtronic’s Reveal device.”
This Food and Drug Administration-approved device is a battery-powered, data storage device that monitors and records a patient’s heart rate and any abnormal arrhythmic activity, day or night; it then transmits the data electronically to a secure website.
Subjects selected to participate in the study include those who are currently on hemodialysis at least three times per week or who will begin hemodialysis within two months of the reveal implant. Regardless of whether or not hemodialysis has been initiated, data from the first six months, beginning with the first dialysis session after implant, will be used.
Subjects will continue to be followed beyond the six-month data collection phase through completion of this study, which is defined as when the last subject completes six months of follow-up care.
"The data from this study could potentially treat the electrolyte abnormalities and shifts associated with hemodialysis as well as reduce the incidence of cardiac problems, including sudden cardiac death,” says Roy-Chaudhury, who adds that the study would not be possible without help from community and UC Health nephrologists.