Just a moment, the page is loading...

Evaluation of acute changes in kidney function with serelaxin in acute heart failure

Evaluation of acute changes in kidney function with serelaxin in acute heart failure

Wendy McCallum, MD, MS

Tufts Medical Center, Tufts University School of Medicine

16 May 2022

Kidney function is primarily assessed by the estimated glomerular filtration rate (eGFR), which is an estimate of how well the kidneys are filtering and removing toxins; the higher the eGFR, the better the kidneys are clearing toxins. Serelaxin is an investigational drug that acts to dilate, or open up, blood vessels in the body. Several studies examining the mechanisms of serelaxin's effects have shown that by improving blood flow to the kidney, it can be associated with an increase in eGFR. In most patient populations, an increase in eGFR has been associated with improved kidney function and thereby improved clinical outcomes; however, in acute heart failure, there are numerous fluctuations in eGFR during the course of the hospitalization, with some prior studies showing that increases in eGFR can actually be associated with increased risk of death. We still have limited understanding of the mechanisms that lead to increases in kidney function during hospitalizations for acute heart failure, and how those increases relate with clinical outcomes. We hypothesize that in the case of serelaxin, an increase in eGFR may be a reflection that the drug is working effectively and causing a medication-related effect to increase the eGFR. In other words, we aim to examine whether a short-term increase in eGFR is associated with mortality, cardiac mortality, or hospitalization for heart failure or renal failure at 180 days. We also aim to examine whether randomization to serelaxin or placebo modifies the relation between the short-term increase in eGFR with clinical outcomes.

[{ "PostingID": 16154, "Title": "NOVARTIS-CRLX030A2301", "Description": "A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients" }]

Statistical Analysis Plan