title: Neural modulation for hypertension and heart failure.
abstract: Hypertension (HTN) and heart failure (HF) have a significant global impact on health, and lead to increased morbidity and mortality. Despite recent advances in pharmacologic and device therapy for these conditions, there is a need for additional treatment modalities. Patients with sub-optimally treated HTN have increased risk for stroke, renal failure and heart failure. The outcome of HF patients remains poor despite modern pharmacological therapy and with established device therapies such as CRT and ICDs. Therefore, the potential role of neuromodulation via renal denervation, baro-reflex modulation and vagal stimulation for the treatment of resistant HTN and HF is being explored. In this manuscript, we review current evidence for neuromodulation in relation to established drug and device therapies and how these therapies may be synergistic in achieving therapy goals in patients with treatment resistant HTN and heart failure. We describe lessons learned from recent neuromodulation trials and outline strategies to improve the potential for success in future trials. This review is based on discussions between scientists, clinical trialists, and regulatory representatives at the 11th annual CardioVascular Clinical Trialist Forum in Washington, DC on December 5-7, 2014.
authors.affiliation: The Ohio State University Wexner Medical Center, Department of Internal Medicine and Division of Cardiology, Columbus, OH, USA. Electronic address: sakima.smith@osumc.edu.
authors.forename: S
authors.initials: S
authors.lastname: Smith
authors.affiliation: Inserm, CIC 1433, Centre Hospitalier Universitaire, Universite´ de Lorraine, F-CRIN INI-CRCT, Nancy, France.
authors.forename: P
authors.initials: P
authors.lastname: Rossignol
authors.affiliation: The Ohio State University Wexner Medical Center, Department of Internal Medicine and Division of Cardiology, Columbus, OH, USA.
authors.forename: S
authors.initials: S
authors.lastname: Willis
authors.affiliation: Inserm, CIC 1433, Centre Hospitalier Universitaire, Universite´ de Lorraine, F-CRIN INI-CRCT, Nancy, France.
authors.forename: F
authors.initials: F
authors.lastname: Zannad
authors.affiliation: Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, NC, USA.
authors.forename: R
authors.initials: R
authors.lastname: Mentz
authors.affiliation: Medical Statistics Unit LSHTM, London, UK.
authors.forename: S
authors.initials: S
authors.lastname: Pocock
authors.affiliation: University of Rochester Medical Center, Department of Medicine, Cardiology, Rochester, NY, USA.
authors.forename: J
authors.initials: J
authors.lastname: Bisognano
authors.affiliation: CVRx, Inc, Minneapolis, MN, USA.
authors.forename: Y
authors.initials: Y
authors.lastname: Nadim
authors.affiliation: Office of Biostatistics Research, Division of Cardiovascular Sciences, NHLBI, National Institutes of Health, Bethesda, MD, USA.
authors.forename: N
authors.initials: N
authors.lastname: Geller
authors.affiliation: Boston Scientific CRV, St. Paul, MN, USA.
authors.forename: S
authors.initials: S
authors.lastname: Ruble
authors.affiliation: Institution of Internal Medicine, Karolinska Institutet and Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden. Electronic address: cecilia.linde@ki.se.
authors.forename: C
authors.initials: C
authors.lastname: Linde
mesh_terms: D000959:Antihypertensive Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D017147:Defibrillators, Implantable; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D006973:Hypertension / Q000628:therapy*; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000379:methods
chemical_list: D000959:Antihypertensive Agents
keywords: Baroreceptor; Heart failure; Hypertension; Neural modulation; Renal denervation