title: A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial).
abstract: OBJECTIVE
  AUGMENT-HF was an international, multi-centre, prospective, randomized, controlled trial to evaluate the benefits and safety of a novel method of left ventricular (LV) modification with alginate-hydrogel.
  
  
  METHODS
  Alginate-hydrogel is an inert permanent implant that is directly injected into LV heart muscle and serves as a prosthetic scaffold to modify the shape and size of the dilated LV. Patients with advanced chronic heart failure (HF) were randomized (1 : 1) to alginate-hydrogel (n = 40) in combination with standard medical therapy or standard medical therapy alone (Control, n = 38). The primary endpoint of AUGMENT-HF was the change in peak VO2 from baseline to 6 months. Secondary endpoints included changes in 6-min walk test (6MWT) distance and New York Heart Association (NYHA) functional class, as well as assessments of procedural safety.
  
  
  RESULTS
  Enrolled patients were 63 ± 10 years old, 74% in NYHA functional class III, had a LV ejection fraction of 26 ± 5% and a mean peak VO2 of 12.2 ± 1.8 mL/kg/min. Thirty-five patients were successfully treated with alginate-hydrogel injections through a limited left thoracotomy approach without device-related complications; the 30-day surgical mortality was 8.6% (3 deaths). Alginate-hydrogel treatment was associated with improved peak VO2 at 6 months-treatment effect vs.
  
  
  METHODS
  +1.24 mL/kg/min (95% confidence interval 0.26-2.23, P = 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both P < 0.001).
  
  
  CONCLUSIONS
  Alginate-hydrogel in addition to standard medical therapy for patients with advanced chronic HF was more effective than standard medical therapy alone for improving exercise capacity and symptoms. The results of AUGMENT-HF provide proof of concept for a pivotal trial.
  
  
  BACKGROUND
  NCT01311791.
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumonology, University Medical Centre Göttingen (UMG), Robert-Koch-Str. 40, Göttingen D-37075, Germany s.anker@cachexia.de.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
authors.affiliation: Monash University, Melbourne, Australia University of Warwick, Warwick, UK.
authors.forename: Andrew J S
authors.initials: AJ
authors.lastname: Coats
authors.affiliation: Military Hospital Bucharest, Bucharest, Romania.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Cristian
authors.affiliation: Spitalul Clinic De Urgenta MAI, Bucharest, Romania.
authors.forename: Dinu
authors.initials: D
authors.lastname: Dragomir
authors.affiliation: IRCCS San Donato, San Donato Milanese, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Pusineri
authors.affiliation: IRCCS San Donato, San Donato Milanese, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Piredda
authors.affiliation: Istituti Ospitalieri di Cremona, Cremona, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Bettari
authors.affiliation: Dowling Consulting, Louisville, KY, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Dowling
authors.affiliation: IRCCS San Raffaele, Rome, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Volterrani
authors.affiliation: SOCAR Research SA, Nyon, Switzerland.
authors.forename: Bridget-Anne
authors.initials: BA
authors.lastname: Kirwan
authors.affiliation: University Hospital Athens, Athens, Greece.
authors.forename: Gerasimos
authors.initials: G
authors.lastname: Filippatos
authors.affiliation: Paris Descartes University, Saint-Anne Hospital, Paris, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Mas
authors.affiliation: Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Danchin
authors.affiliation: Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.affiliation: Department of Medicine, University of California-San Francisco, San Francisco, CA, USA.
authors.forename: Randall J
authors.initials: RJ
authors.lastname: Lee
authors.affiliation: LoneStar Heart Inc., Laguna Hills, CA, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Ahmann
authors.affiliation: LoneStar Heart Inc., Laguna Hills, CA, USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Hinson
authors.affiliation: Henry Ford Health System, Detroit, MI, USA.
authors.forename: Hani N
authors.initials: HN
authors.lastname: Sabbah
authors.affiliation: Washington University School of Medicine, Barnes Jewish Hospital, St. Louis, MO, USA.
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Mann
mesh_terms: D000464:Alginates / Q000008:administration & dosage*; D004452:Echocardiography; D005080:Exercise Test; D017079:Exercise Tolerance / Q000502:physiology; D005260:Female; D020723:Glucuronic Acid / Q000008:administration & dosage; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006603:Hexuronic Acids / Q000008:administration & dosage; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000008:administration & dosage*; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010101:Oxygen Consumption / Q000502:physiology; D061214:Patient Safety; D011446:Prospective Studies; D019736:Prostheses and Implants; D011788:Quality of Life; D016896:Treatment Outcome; D016138:Walking / Q000502:physiology
chemical_list: D000464:Alginates; D006603:Hexuronic Acids; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D020723:Glucuronic Acid
keywords: Advanced chronic heart failure; Alginate-hydrogel; Exercise capacity; Safety; Symptoms