Standardized Definitions of Changes in Kidney Function in Trials of Heart Failure

Abstract

Perturbations in kidney function are frequently encountered in heart failure (HF) across its spectrum in both chronic and acute settings with distinct implications for patient management and prognosis. Lack of consensus on the threshold for clinically meaningful changes in kidney function has led to heterogeneity in the clinical characteristics and background therapies of individuals enrolled in clinical trials, and in multiple aspects of trial design. A meaningful and collaborative interaction among the disciplines of cardiology and nephrology, clinical trialists, industry sponsors, and regulatory agencies is vital to the development of standardized definitions of changes in kidney function across HF settings. To achieve this critically important objective, the Heart Failure Collaboratory assembled experts in HF and nephrology, including key stakeholders in the U.S. Food and Drug Administration and industry, with the goal of developing initial recommendations for improved standardization of design and conduct of clinical trials in HF. Recommendations included how and when to measure baseline and changes in kidney function, discouraging the use of the term “acute kidney injury,” and the consideration of urinary markers in the assessment of kidney function.