title: One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.
abstract: OBJECTIVE
  AUGMENT-HF was an international, multicentre, prospective, open-label, randomized, controlled evaluation testing the hypothesis that Algisyl (injectable calcium alginate hydrogel) is superior to standard medical therapy (SMT) for improving functional capacity and clinical outcomes in patients with advanced heart failure (HF). We previously reported results following 6 months of follow-up. This report presents the results from 1 year of extended follow up for this clinical trial.
  
  
  RESULTS
  We enrolled 78 patients with advanced HF, randomized (1:1), to Algisyl with SMT or SMT alone as previously reported. Patient inclusion criteria were LVEF ≤35%, peak VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m(2) (LVEDD/body surface area). Patients must have been on stable, evidence-based therapy for HF. A total of 58 patients, mean age 62.3 ± 9.6 years, with ischaemic (57.7%) or non-ischaemic (42.3%) HF completed 12 months of follow-up. Treatment with Algisyl was associated with improved peak VO2 at 12 months; treatment effect vs. control of +2.10 mL/kg/min (95% confidence interval 0.96-3.24, P < 0.001). Statistically significant improvements were observed for VO2 at anaerobic threshold, 6-min walk test distance, and NYHA functional class (all P < 0.001). Through 12 months of follow-up there were 4 (10.5%) deaths in the control group and 9 (22.5%) deaths in the Algisyl group.
  
  
  CONCLUSIONS
  Algisyl in addition to SMT was more effective than SMT alone for providing sustained 1-year benefits in exercise capacity, symptoms, and clinical status for patients with advanced HF. These data support larger clinical evaluations of this novel therapy.
authors.affiliation: Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO, USA.
authors.forename: Douglas L
authors.initials: DL
authors.lastname: Mann
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: Monash University, Melbourne, Australia and 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: Gheorghe
authors.initials: G
authors.lastname: Neagoe
authors.affiliation: Spitalul Clinic De Urgenta MAI, Bucharest, Romania.
authors.forename: Dinu
authors.initials: D
authors.lastname: Dragomir
authors.affiliation: Cardio-thoracic Center, Istituto Clinico Sant'Ambrogio, Milan, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Pusineri
authors.affiliation: Cardio-thoracic Center, Istituto Clinico Sant'Ambrogio, Milan, 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: SOCAR Research SA, Nyon, Switzerland.
authors.forename: Bridget-Anne
authors.initials: BA
authors.lastname: Kirwan
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: Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.affiliation: Henry Ford Health System, Detroit, MI, USA.
authors.forename: Hani N
authors.initials: HN
authors.lastname: Sabbah
authors.affiliation: LoneStar Heart Inc., Laguna Hills, CA, USA.
authors.forename: Andy
authors.initials: A
authors.lastname: Hinson
authors.affiliation: Innovative Clinical Trials, Department of Cardiology and Pneumonology, University Medical Centre Göttingen (UMG), Göttingen, Germany.
authors.forename: Stefan D
authors.initials: SD
authors.lastname: Anker
mesh_terms: D000368:Aged; D000464:Alginates / Q000008:administration & dosage*; D001672:Biocompatible Materials / Q000008:administration & dosage*; D004452:Echocardiography; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D005500:Follow-Up Studies; D020723:Glucuronic Acid / Q000008:administration & dosage; D006333:Heart Failure / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006352:Heart Ventricles / Q000503:physiopathology*; D006603:Hexuronic Acids / Q000008:administration & dosage; D006801:Humans; D020100:Hydrogels / Q000008:administration & dosage; D007267:Injections; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000464:Alginates; D001672:Biocompatible Materials; D006603:Hexuronic Acids; D020100:Hydrogels; D020723:Glucuronic Acid
keywords: Alginate hydrogel; Heart failure; Tissue engineering