Defining Clinically Meaningful Within-Patient Changes in Heart Failure: JACC: Heart Failure Position Statement

Document Type

Article

Publication Date

10-1-2026

Publication Title

JACC Heart Fail

Keywords

Humans, Heart Failure, Patient Reported Outcome Measures, Biomarkers, Prognosis

Abstract

Heart failure (HF) clinical trials increasingly rely on diverse endpoints beyond mortality, including hospitalizations, imaging, hemodynamic status, biomarkers, functional capacity, and patient-reported outcomes. Although statistically significant differences between treatment groups are commonly reported, interpreting whether these changes are clinically meaningful for individual patients remains challenging. This JACC: Heart Failure position statement proposes a pragmatic framework for defining clinically meaningful within-patient change across commonly used HF outcomes by integrating measurement variability, prognostic associations, and patient-anchored evidence where available. Relative and absolute risk reductions should both inform interpretation of clinical events, while imaging, hemodynamic, biomarker, and functional measures require changes exceeding measurement variability and consideration of physiological context. Patient-reported health status measures, particularly the Kansas City Cardiomyopathy Questionnaire, currently have the strongest evidence supporting clinically meaningful thresholds. Many proposed cutpoints remain provisional, reflecting limited validation linking physiological changes to patient-perceived benefit or hard outcomes. Future work should prioritize anchor-based analyses and patient-centered validation to align trial results with shared decision-making.

Medical Subject Headings

Humans; Heart Failure; Patient Reported Outcome Measures; Biomarkers; Prognosis

PubMed ID

42687463

Volume

14

Issue

10

First Page

103310

Last Page

103310

Find It @ Sladen

Share

COinS