Standardized definitions for evaluation of acute decompensated heart failure therapies: HF-ARC expert panel paper

Anuradha Lala, Zena and Michael A. Wiener Cardiovascular Institute and Department of Population Health Science and Policy, Mount Sinai, New York, New York, USA. Electronic address: Anu.lala@mountsinai.org.
Carine E. Hamo, New York University School of Medicine, Leon H. Charney Division of Cardiology, New York University Langone Health, New York, New York, USA.
Biykem Bozkurt, Winters Center for Heart Failure, Cardiology, Baylor College of Medicine and Michael E. DeBakey VA Medical Center, Houston, Texas, USA.
Mona Fiuzat, Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Vanessa Blumer, Department of Cardiovascular Medicine, Heart and Vascular Institute, Kaufman Center for Heart Failure, Cleveland Clinic, Cleveland, Ohio, USA.
Daniel Bukhoff, Division of Cardiology, Tufts Medical Center, Boston, Massachusetts, USA; Cardiovascular Research Foundation, New York, New York, USA.
Javed Butler, Baylor Scott & White Research Institute, Dallas, Texas, USA; University of Mississippi Medical Center, Jackson, Mississippi, USA.
Maria Rosa Costanzo, Advocate Aurora Health
G Michael Felker, Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Gerasimos Filippatos, University of Cyprus Medical School, Shakolas Educational Center for Clinical Medicine, Nicosia, Cyprus.
Marvin A. Konstam, The CardioVascular Center of Tufts Medical Center, Boston, Massachusetts, USA.
John J. McMurray, British Heart Foundation Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland.
Robert J. Mentz, Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA.
Marco Metra, Cardiology, Cardio-Thoracic Department, Civil Hospitals; Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
Mitchell A. Psotka, Inova Heart and Vascular Institute, Falls Church, Virginia, USA.
Scott D. Solomon, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
John Teerlink, Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California, USA.
William T. Abraham, Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.
Christopher M. O'Connor, Division of Cardiology, Duke University School of Medicine, Durham, North Carolina, USA; Inova Heart and Vascular Institute, Falls Church, Virginia, USA.

Affiliations

Advocate Heart Institute, Naperville

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 multi-stakeholder 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.

Document Type

Article

PubMed ID

38069997

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