Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

Anuradha Lala; Carine E Hamo; Biykem Bozkurt; Mona Fiuzat; Vanessa Blumer; Daniel Bukhoff; Javed Butler; Maria Rosa Costanzo; G Michael Felker; Gerasimos Filippatos; Marvin A Konstam; John J V McMurray; Robert J Mentz; Marco Metra; Mitchell A Psotka; Scott D Solomon; John Teerlink; William T Abraham; Christopher M O'Connor; HF-ARC (Heart Failure Collaboratory and Academic Research Consortium)

doi:10.1016/j.jchf.2023.09.030

Standardized Definitions for Evaluation of Acute Decompensated Heart Failure Therapies: HF-ARC Expert Panel Paper

JACC Heart Fail. 2024 Jan;12(1):1-15. doi: 10.1016/j.jchf.2023.09.030. Epub 2023 Dec 6.

Authors

Anuradha Lala¹, Carine E Hamo², Biykem Bozkurt³, Mona Fiuzat⁴, Vanessa Blumer⁵, Daniel Bukhoff⁶, Javed Butler⁷, Maria Rosa Costanzo⁸, G Michael Felker⁴, Gerasimos Filippatos⁹, Marvin A Konstam¹⁰, John J V McMurray¹¹, Robert J Mentz⁴, Marco Metra¹², Mitchell A Psotka¹³, Scott D Solomon¹⁴, John Teerlink¹⁵, William T Abraham¹⁶, Christopher M O'Connor¹⁷; HF-ARC (Heart Failure Collaboratory and Academic Research Consortium)

Affiliations

¹ Zena and Michael A. Wiener Cardiovascular Institute and Department of Population Health Science and Policy, Mount Sinai, New York, New York, USA. Electronic address: [email protected].
² New York University School of Medicine, Leon H. Charney Division of Cardiology, New York University Langone Health, New York, New York, USA.
³ Winters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E. DeBakey VA Medical Center, Houston, Texas, USA.
⁴ Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
⁵ Department of Cardiovascular Medicine, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio, USA.
⁶ Division of Cardiology, Tufts Medical Center, Boston, Massachusetts, USA; Cardiovascular Research Foundation, New York, New York, USA.
⁷ Baylor Scott & White Research Institute, Dallas, Texas, USA; University of Mississippi Medical Center, Jackson, Mississippi, USA.
⁸ Advocate Heart Institute, Naperville, Illinois, USA.
⁹ University of Cyprus Medical School, Shakolas Educational Center for Clinical Medicine, Nicosia, Cyprus.
¹⁰ The CardioVascular Center of Tufts Medical Center, Boston, Massachusetts, USA.
¹¹ British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland.
¹² Cardiology, Cardio-Thoracic Department, Civil Hospitals; Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
¹³ Inova Heart and Vascular Institute, Falls Church, Virginia, USA.
¹⁴ Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
¹⁵ Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California-San Francisco, San Francisco, California, USA.
¹⁶ Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
¹⁷ Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA; Inova Heart and Vascular Institute, Falls Church, Virginia, USA.

PMID: 38069997
DOI: 10.1016/j.jchf.2023.09.030

Abstract

Acute decompensated heart failure (ADHF) is one of the most common reasons for hospitalizations or urgent care and is associated with poor outcomes. Therapies shown to improve outcomes are limited, however, and innovation in pharmacologic and device-based therapeutics are therefore actively being sought. Standardizing definitions for ADHF and its trajectory is complex, limiting the generalizability and translation of clinical trials to effect clinical care and policy change. The Heart Failure Collaboratory is a multistakeholder organization comprising clinical investigators, clinicians, patients, government representatives (including U.S. Food and Drug Administration and National Institutes of Health participants), payors, and industry collaborators. The following expert consensus document is the product of the Heart Failure Collaboratory convening with the Academic Research Consortium, including members from academia, the U.S. Food and Drug Administration, and industry, for the purposes of proposing standardized definitions for ADHF and highlighting important endpoint considerations to inform the design and conduct of clinical trials for drugs and devices in this clinical arena.

Keywords: endpoints; heart failure; hospitalization; mortality.

Publication types

Review
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Heart Failure* / therapy
Heart Valve Prosthesis Implantation*
Hospitalization
Humans

Grants and funding

R18 FD006920/FD/FDA HHS/United States