Heart failure is common in patients with kidney failure undergoing dialysis, but it is often difficult to distinguish from other conditions with similar symptoms, such as volume overload. For this reason, it is critically important to have standardized diagnostic criteria in randomized clinical trials (RCTs) in order to accurately assess treatment effects.
In a recent meta-epidemiologic study published in Nephrology Dialysis Transplantation, led by CVC faculty member Dr. David Collister, researchers examined the reporting, diagnostic criteria, and adjudication of heart failure events in RCTs with patients receiving maintenance dialysis for kidney failure.
The researchers examined 561 RCTs published in high-impact journals between 2000 and 2020, finding that only 36 (6.4%) of these trials reported heart failure events as primary or secondary outcomes. Of these 36 trials, 10 (27.8%) provided diagnostic criteria for heart failure events, with varied criteria across trials, and half of those included event adjudication. The researchers found that none of the studies made a clear distinction between heart failure and volume overload caused by factors like non-adherence with dietary sodium/fluid restriction or dialysis.
Their findings demonstrate that heart failure events are rarely reported in dialysis-related RCTs and that definitions of these events lack specificity. Dr. Collister notes that “this study is an important first step to standardize a heart failure event definition across clinical trials in maintenance dialysis that is meaningful to patients, healthcare providers, researchers and regulators.”
