Authors
Amin Yehya, Rebecca Hahn, Barry Borlaug, Victoria Delgado, Andrew Ambrosy, Ross Arena, Nosheen Reza, Gregory Lewis, Natalie Tapaskar, Salvatore Carbone, Cynthia Chauhan, Mitchell A Psotka, Norman Stockbridge, James Januzzi, Javed Butler, Jennifer Cowger, Biykem Bozkurt, John Spertus
Published in
JACC. Heart failure. Pages 103310. Sep 01, 2026. Epub Sep 01, 2026.
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.
PMID:
42687463
Bibliographic data and abstract were imported from PubMed on 03 Sep 2026.
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