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

Authors

• Amin Yehya, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Rebecca Hahn, Columbia University Irving Medical Center
• Barry Borlaug, Mayo Clinic
• Victoria Delgado, Hospital University Germans Trias I Pujol
• Andrew Ambrosy, Kaiser Permanente Northern California
• Ross Arena, University of Illinois Chicago
• Nosheen Reza, Hospital of the University of Pennsylvania
• Gregory Lewis, Mass General Brigham
• Natalie Tapaskar, University of Texas Southwestern Medical Center
• Salvatore Carbone, Macon & Joan Brock Virginia Health Sciences at Old Dominion UniversityFollow
• Cynthia Chauhan, Wichita, Kansas
• Mitchell A. Psotka, Inova Schar Heart and Vascular
• Norman Stockbridge, S & S Consulting Partners
• James Januzzi, Wichita, Kansas
• Javed Butler, Baylor Scott & White Research Institute
• Jennifer Cowger, Sentara Heart Hospital
• Biykem Bozkurt, Baylor College of Medicine
• John Spertus, Sait Luke's Mid America Heart Institute

ORCID

0000-0001-5947-4778 (Yehya), 0000-0002-8163-0527 (Carbone)

Document Type

Article

Publication Date

2026

DOI

10.1016/j.jchf.2026.103310

Publication Title

JACC: Heart Failure

Volume

Advance online publication

Pages

22 pp.

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.

Rights

© 2026 The Authors.

This is an open access article under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) License.

Original Publication Citation

Yehya, A., Hahn, R., Borlaug, B., Delgado, V., Ambrosy, A., Arena, R., Reza, N., Lewis, G., Tapaskar, N., Carbone, S., Chauhan, C., Psotka, M. A., Stockbridge, N., Januzzi, J., Butler, J., Cowger, J., Bozkurt, B., & Spertus, J. (2026). Defining clinically meaningful within-patient changes in heart failure: JACC: Heart Failure position statement. JACC: Heart Failure. Advance online publication. https://doi.org/10.1016/j.jchf.2026.103310

Repository Citation

Yehya, A., Hahn, R., Borlaug, B., Delgado, V., Ambrosy, A., Arena, R., Reza, N., Lewis, G., Tapaskar, N., Carbone, S., Chauhan, C., Psotka, M. A., Stockbridge, N., Januzzi, J., Butler, J., Cowger, J., Bozkurt, B., & Spertus, J. (2026). Defining clinically meaningful within-patient changes in heart failure: JACC: Heart Failure position statement. JACC: Heart Failure. Advance online publication. https://doi.org/10.1016/j.jchf.2026.103310