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Publications

Journal Article Consensus Statement Review Ppublish

PubMed: 42687463 DOI: 10.1016/j.jchf.2026.103310

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

JACC Heart Fail 14(10):103310

Authors: Amin Yehya, Rebecca Hahn, Barry Borlaug, Victoria Delgado, Andrew Ambrosy, Ross Arena, Nosheen Reza, Gregory D Lewis, Natalie Tapaskar, Salvatore Carbone, Cynthia Chauhan, Mitchell A Psotka, Norman Stockbridge, James Januzzi, Javed Butler, Jennifer Cowger, Biykem Bozkurt, John Spertus

Affiliations

  • Department of Cardiology, Sentara Heart Hospital, Norfolk, Virginia, USA.
  • Department of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
  • Department of Cardiology, Mayo Clinic, Rochester, Minnesota, USA.
  • Department of Cardiology, Hospital University Germans Trias I Pujol, Badalona, Spain.
  • Division of Research, Kaiser Permanente Northern California, San Francisco, California, USA.
  • Department of Physical Therapy, University of Illinois Chicago, Chicago, Illinois, USA.
  • Department of Cardiology, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Department of Cardiology, Mass General Brigham, Boston, Massachusetts, USA.
  • Department of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
  • Nutrition Program, Old Dominion University, Norfolk, Virginia, USA.
  • Wichita, Kansas, USA (Patient Advocate).
  • Inova Schar Heart and Vascular, Falls Church, Virginia, USA.
  • S & S Consulting Partners, Silver Spring, Maryland, USA.
  • Department of Medicine, Baylor Scott & White Research Institute, Houston, Texas, USA.
  • Department of Cardiology, Henry Ford Hospital, Detroit, Michigan, USA.
  • Division of Cardiology, Baylor College of Medicine, Houston, Texas, USA.
  • Department of Cardiology, Saint Luke's Mid America Heart Institute, Kansas City, Missouri, USA.

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.

MeSH

Research Design, Heart Failure, Heart, Biomarkers, Work, Hemodynamics