title: Renal denervation therapy for hypertension: pathways for moving development forward.
abstract: This scientific statement provides a summary of presentations and discussions at a cardiovascular Think Tank co-sponsored by the American Society of Hypertension (ASH), the United States Food and Drug Administration (FDA), and the National Heart, Lung, and Blood Institute (NHLBI) held in North Bethesda, Maryland, on June 26, 2014. Studies of device therapies for the treatment of hypertension are requested by regulators to evaluate their safety and efficacy during their development programs. Think Tank participants thought that important considerations in undertaking such studies were: (1) Preclinical assessment: how likely it is that both efficacy and safety data indicating benefit in humans will be obtained, and/or whether a plausible mechanism of action for efficacy can be identified; (2) Early human trial(s): the ability to determine that the device has an acceptable benefit-to-risk balance for its use in the intended patient population and without the influence of drug therapy during a short-term follow-up period; and (3) Pivotal Phase III trial(s): the ability to prove the effectiveness of the device in a broad population in which the trial can be made as non-confounded as possible while still allowing for the determination for benefits when added to antihypertensive therapies.
authors.affiliation: Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, CT, USA. Electronic address: wwhite@uchc.edu.
authors.forename: William B
authors.initials: WB
authors.lastname: White
authors.affiliation: National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
authors.forename: Zorina S
authors.initials: ZS
authors.lastname: Galis
authors.affiliation: University of Missouri, Columbia, MO, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Henegar
authors.affiliation: Piedmont Heart Institute, Atlanta, GA, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Ronald
authors.initials: R
authors.lastname: Victor
authors.affiliation: Virginia Commonwealth University Medical Center, Richmond, VA, USA.
authors.forename: Domenic
authors.initials: D
authors.lastname: Sica
authors.affiliation: University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
authors.forename: Raymond R
authors.initials: RR
authors.lastname: Townsend
authors.affiliation: Clinical Communications, Quintiles, Durham, NC, USA.
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
authors.affiliation: CVPath Institute, Gaithersburg, MD, USA.
authors.forename: Renu
authors.initials: R
authors.lastname: Virmani
authors.affiliation: Harvard Clinical Research Institute and Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000818:Animals; D000959:Antihypertensive Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000032:analysis; D002986:Clinical Trials as Topic; D003714:Denervation / Q000379:methods*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy / Q000503:physiopathology / Q000601:surgery*; D007668:Kidney / Q000294:innervation*
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers
keywords: American Society of Hypertension; clinical trials; device therapy for hypertension; renal denervation