title: Biomarker-guided therapies in heart failure: a forum for unified strategies.
abstract: The complexity of standard medical treatment for heart failure is growing, and such therapy typically involves 5 or more different medications. Given these pressures, there is increasing interest in harnessing cardiovascular biomarkers for clinical application to more effectively guide diagnosis, risk stratification, and therapy. It may be possible to realize an era of personalized medicine for heart failure treatment in which therapy is optimized and costs are controlled. The direct mechanistic coupling of biologic processes and therapies achieved in cancer treatment remains elusive in heart failure. Recent clinical trials and meta-analyses of biomarkers in heart failure have produced conflicting evidence. In this article, which comprises a summary of discussions from the Global Cardiovascular Clinical Trialists Forum held in Paris, France, we offer a brief overview of the background and rationale for biomarker testing in heart failure, describe opportunities and challenges from a regulatory perspective, and summarize current positions from government agencies in the United States and European Union.
authors.affiliation: Duke University Medical Center, Durham, North Carolina 27705, USA. mona.fiuzat@duke.edu
authors.forename: Mona
authors.initials: M
authors.lastname: Fiuzat
authors.forename: Christopher M
authors.initials: CM
authors.lastname: O'Connor
authors.forename: Francois
authors.initials: F
authors.lastname: Gueyffier
authors.forename: Alice M
authors.initials: AM
authors.lastname: Mascette
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Geller
authors.forename: Alexandre
authors.initials: A
authors.lastname: Mebazaa
authors.forename: Adriaan A
authors.initials: AA
authors.lastname: Voors
authors.forename: Kirkwood F
authors.initials: KF
authors.lastname: Adams
authors.forename: Ileana L
authors.initials: IL
authors.lastname: Piña
authors.forename: Ludwig
authors.initials: L
authors.lastname: Neyses
authors.forename: Pieter
authors.initials: P
authors.lastname: Muntendam
authors.forename: G Michael
authors.initials: GM
authors.lastname: Felker
authors.forename: Bertram
authors.initials: B
authors.lastname: Pitt
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
authors.forename: Michael R
authors.initials: MR
authors.lastname: Bristow
mesh_terms: D015415:Biomarkers / Q000378:metabolism; D005060:Europe / Q000453:epidemiology; D005062:European Union; D006333:Heart Failure / Q000453:epidemiology / Q000378:metabolism* / Q000628:therapy*; D006801:Humans; D010297:Paris; D016032:Randomized Controlled Trials as Topic / Q000639:trends; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D015415:Biomarkers
keywords: Pharmacogenetics; biologic markers; cardiovascular diseases; clinical trials