title: First Clinical Experience With Targeted REnal Nerve Demodulation (TREND-1) Using a Neurotropic Agent for the Treatment of Sympathetic Hypertension.
abstract: OBJECTIVE
  To evaluate the feasibility and safety of a novel targeted neuromodulatory treatment for sympathetic hypertension involving a one-time local injection of neurotropic agents near renal nerves.
  
  
  RESULTS
  Seven patients suffering from uncontrolled hypertension per ESH-ESC guidelines were treated using a single dose of NW2013, a neurotropic Na+/K+ ATPase antagonist. A microneedle catheter was used to administer 1.2 mL of NW2013 (0.6 mL per artery) to the perivascular space surrounding renal arteries using percutaneous endovascular procedures under fluoroscopic guidance. All patients were successfully treated without any procedural complications. Patients were followed for 12 months post procedure, and office and 24-hour ambulatory blood pressure measurements were made. Both office and ambulatory blood pressures were lower at 24 hours, 1 month, and 3 months after treatment. The decrease in office blood pressure was greater than the decrease in ambulatory blood pressure. A reduction in medication regimen was also observed in 2 patients. One patient suffered a cerebrovascular event after 6-month follow-up and died from stroke, unrelated to the treatment. Overall, the reduction in office and ambulatory blood pressure was sustained over the course of 12 months.
  
  
  CONCLUSIONS
  Treatment of hypertension using local administration of NW2013 near renal nerves appears to be feasible and safe. Large, controlled, randomized, and blinded clinical studies with monitoring of patient compliance to daily oral medication are recommended to further establish the efficacy of this novel treatment.
authors.affiliation: Molecular and Endoluminal Coronary Interventions, Interventional Cardiology, 130 E. 77th Street, New York, NY 10021 USA. nkipshidze@lenoxhill.net.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Kipshidze
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Michael H
authors.initials: MH
authors.lastname: Wholey
authors.forename: Konstantin
authors.initials: K
authors.lastname: Kipiani
authors.forename: Vakhtang
authors.initials: V
authors.lastname: Kipiani
authors.forename: Tea
authors.initials: T
authors.lastname: Mukhuradze
authors.forename: Mark
authors.initials: M
authors.lastname: Wholey
authors.forename: Emily
authors.initials: E
authors.lastname: Stein
authors.forename: K T
authors.initials: KT
authors.lastname: Venkateswara Rao
mesh_terms: D000359:Aftercare / Q000379:methods; D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D018660:Blood Pressure Monitoring, Ambulatory / Q000379:methods; D057510:Endovascular Procedures / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018377:Neurotransmitter Agents / Q000008:administration & dosage; D012077:Renal Artery / Q000294:innervation; D000254:Sodium-Potassium-Exchanging ATPase / Q000037:antagonists & inhibitors*; D013563:Sympathectomy, Chemical / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D018377:Neurotransmitter Agents; D000254:Sodium-Potassium-Exchanging ATPase