title: Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps.
abstract: Heart failure (HF) is a major and increasing global public health problem. In Asia, aging populations and recent increases in cardiovascular risk factors have contributed to a particularly high burden of HF, with outcomes that are poorer than those in the rest of the world. Representation of Asians in landmark HF trials has been variable. In addition, HF patients from Asia demonstrate clinical differences from patients in other geographic regions. Thus, the generalizability of some clinical trial results to the Asian population remains uncertain. In this article, we review differences in HF phenotype, HF management, and outcomes in patients from East and Southeast Asia. We describe lessons learned in Asia from recent HF registries and clinical trial databases and outline strategies to improve the potential for success in future trials. This review is based on discussions among scientists, clinical trialists, industry representatives, and regulatory representatives at the CardioVascular Clinical Trialist Asia Forum in Singapore on July 4, 2014.
authors.affiliation: Duke Clinical Research Institute and the Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina. Electronic address: robert.mentz@duke.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Mentz
authors.affiliation: Bayer HealthCare, Wuppertal, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Roessig
authors.affiliation: Division of Cardiology, University of California San Diego, San Diego, California.
authors.forename: Barry H
authors.initials: BH
authors.lastname: Greenberg
authors.affiliation: Internal Medicine, Cardiology, and Intensive Care Medicine, Nippon Medical School Musashi-Kosugi Hospital, Kawasaki, Kanagawa, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Sato
authors.affiliation: Office of New Drug II, Pharmaceuticals and Medical Devices Agency, Chiyoda-ku, Tokyo, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Shinagawa
authors.affiliation: Gleneagles Hospital, Singapore.
authors.forename: Daniel
authors.initials: D
authors.lastname: Yeo
authors.affiliation: Farrer Park Medical Centre, Singapore.
authors.forename: Bernard W K
authors.initials: BW
authors.lastname: Kwok
authors.affiliation: Cardiology, Manila Doctors Hospital, Manila, Philippines.
authors.forename: Eugenio B
authors.initials: EB
authors.lastname: Reyes
authors.affiliation: Centre of Cardiovascular Research and Education in Therapeutics, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.
authors.forename: Henry
authors.initials: H
authors.lastname: Krum
authors.affiliation: Department of Cardiology, Charité University Medicine, Campus Virchow Klinikum, and German Heart Center Berlin, Berlin, Germany.
authors.forename: Burkert
authors.initials: B
authors.lastname: Pieske
authors.affiliation: Duke Clinical Research Institute and the Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Greene
authors.affiliation: Duke Clinical Research Institute and the Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Ambrosy
authors.affiliation: Duke Clinical Research Institute and the Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina.
authors.forename: Jacob P
authors.initials: JP
authors.lastname: Kelly
authors.affiliation: INSERM, Centre d'Investigations Cliniques-Plurithématique 1433, Vandoeuvre-lès-Nancy, France; INSERM U1116, Nancy, France; Université de Lorraine, Nancy, France; CHU Nancy, Pôle de Cardiologie, Institut Lorrain du Cœur et des Vaisseaux, Vandoeuvre-lès-Nancy, France; F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.affiliation: University of Michigan School of Medicine, Ann Arbor, Michigan.
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.affiliation: National Heart Centre Singapore and Duke-National University of Singapore, Singapore.
authors.forename: Carolyn S P
authors.initials: CS
authors.lastname: Lam
mesh_terms: D001210:Asia, Southeastern; D044466:Asian People; D002986:Clinical Trials as Topic; D005202:Asia, Eastern; D006333:Heart Failure / Q000208:ethnology / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D010641:Phenotype
keywords: Asia; heart failure; trials