RenalGuard’s New Heart Failure Trial Results

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RenalGuard Solutions has announced results for an additional patient population with a form of heart failure. The Milford, MA, company demonstrated the ability of RenalGuard-Guided Diuretic Therapy to control and optimize fluid management in patients with acute decompensated heart failure. Heart failure is common in patients with CKD and end stage renal failure.

RenalGuard measures urine output and automatically infuses saline (hydration fluid) according to the ideal present fluid loss limits set by the physician.

Patients in the trial started with an initial 24 hours of standard treatment with furosemide (brand name Lasix, a loop diuretic), followed by 24 hours using the RenalGuard system.

The device alleviated symptoms related to heart failure, improving breathing patterns and increasing urine output. The device was designed to measure a patient’s urine output and to respond by infusing hydration fluid based on the urine output level.

The company noted that during the RenalGuard cycle, patients developed more than a 2.5-fold increase in the amount of urine they produced. With furosemide, urine output averaged 1961 mL in 24 hours. With RenalGuard, urine output increased to an average of 4771 mL in 24 hours.

By day 30 after the trial, patients showed an average increase in the glomerular filtration rate of 8%. Three patients showed an increase of more than 25%.

In January 2018, RenalGuard announced positive results in patients with congestive heart failure. In that study, 10 patients used RenalGuard to manage fluids during diuretic therapy. It was the first-in-humans feasibility study focusing on a novel use of the RenalGuard System to manage fluids during diuretic therapy in congestive heart failure patients suffering from fluid overload.

A number of studies had already demonstrated RenalGuard’s ability to protect patients from acute kidney injury following catheterization procedures when compared to the standard of care, including the MYTHOS trial, which found use of RenalGuard was superior to overnight hydration and the REMEDIAL II trial, which found RenalGuard was superior to sodium bicarbonate hydration.