title: Natriuretic Peptides, 6-Min Walk Test, and Quality-of-Life Questionnaires as Clinically Meaningful Endpoints in HF Trials.
abstract: The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions document was issued as a guidance for industry and for the Food and Drug Administration. The Expedited Access Pathway was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The Food and Drug Administration would consider assessments of a device's effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit. The purpose of this review is to provide evidence to support the use of 3 such intermediate endpoints: natriuretic peptides, such as N-terminal pro-B-type natriuretic peptide/B-type natriuretic peptide, the 6-min walk test distance, and health-related quality of life in heart failure.
authors.affiliation: INSERM, Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France.
authors.forename: João Pedro
authors.initials: JP
authors.lastname: Ferreira
authors.affiliation: INSERM, Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France.
authors.forename: Kevin
authors.initials: K
authors.lastname: Duarte
authors.affiliation: Berry Consultants LLC, Austin, Texas.
authors.forename: Todd L
authors.initials: TL
authors.lastname: Graves
authors.affiliation: Medical University of South Carolina and the RHJ Department of Veterans Affairs Medical Center, Charleston, South Carolina.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Zile
authors.affiliation: Ohio State University, Columbus, Ohio.
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.affiliation: Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, University of Southern California, Los Angeles, California.
authors.forename: Fred A
authors.initials: FA
authors.lastname: Weaver
authors.affiliation: Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
authors.forename: JoAnn
authors.initials: J
authors.lastname: Lindenfeld
authors.affiliation: INSERM, Centre d'Investigations Cliniques Plurithématique 1433, Université de Lorraine, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France. Electronic address: f.zannad@chru-nancy.fr.
authors.forename: Faiez
authors.initials: F
authors.lastname: Zannad
mesh_terms: D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic; D006333:Heart Failure / Q000097:blood / Q000175:diagnosis / Q000523:psychology; D006801:Humans; D045265:Natriuretic Peptides / Q000097:blood*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D000070857:Walk Test / Q000379:methods*
chemical_list: D015415:Biomarkers; D045265:Natriuretic Peptides
keywords: heart failure trials; natriuretic peptides; surrogate endpoints