title: Established and Emerging Roles of Biomarkers in Heart Failure Clinical Trials.
abstract: The role of circulating biomarkers in heart failure clinical trials has evolved in recent decades. Increasing evidence behind the use of natriuretic peptides, emergence of novel biomarkers, and increased emphasis on targeting therapies toward physiological basis of disease (so-called precision medicine) have all contributed to the continued expansion of biomarker use in heart failure clinical trials. We will explore the advantages and pitfalls encountered through the use of biomarkers in clinical trials as an inclusion criterion, toxicity marker, and end point. We will also review their role in providing insights into the mechanism of action of therapeutics and guiding therapy in the management of patients with heart failure.
authors: From the Cardiology Division, Massachusetts General Hospital, Boston (N.E.I., H.K.G., J.L.J.); Harvard Clinical Research Institute, Boston, MA (H.K.G., J.L.J.); and The Cardiovascular Center, Tufts Medical Center, Boston, MA (M.A.K.).
authors: Nasrien E
authors: NE
authors: Ibrahim
authors: From the Cardiology Division, Massachusetts General Hospital, Boston (N.E.I., H.K.G., J.L.J.); Harvard Clinical Research Institute, Boston, MA (H.K.G., J.L.J.); and The Cardiovascular Center, Tufts Medical Center, Boston, MA (M.A.K.).
authors: Hanna K
authors: HK
authors: Gaggin
authors: From the Cardiology Division, Massachusetts General Hospital, Boston (N.E.I., H.K.G., J.L.J.); Harvard Clinical Research Institute, Boston, MA (H.K.G., J.L.J.); and The Cardiovascular Center, Tufts Medical Center, Boston, MA (M.A.K.).
authors: Marvin A
authors: MA
authors: Konstam
authors: From the Cardiology Division, Massachusetts General Hospital, Boston (N.E.I., H.K.G., J.L.J.); Harvard Clinical Research Institute, Boston, MA (H.K.G., J.L.J.); and The Cardiovascular Center, Tufts Medical Center, Boston, MA (M.A.K.). jjanuzzi@partners.org.
authors: James L
authors: JL
authors: Januzzi
mesh_terms: D015415:Biomarkers / Q000097:blood*; D002986:Clinical Trials as Topic / Q000379:methods*; D023381:Endpoint Determination; D006333:Heart Failure / Q000097:blood* / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D018579:Patient Selection; D057285:Precision Medicine; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors
chemical_list: D015415:Biomarkers
keywords: biomarkers; heart failure; natriuretic peptides; precision medicine; retrospective study