Premium
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
Author(s) -
Mann Douglas L.,
Lee Randall J.,
Coats Andrew J.S.,
Neagoe Gheorghe,
Dragomir Dinu,
Pusineri Enrico,
Piredda Massimo,
Bettari Luca,
Kirwan BridgetAnne,
Dowling Robert,
Volterrani Maurizio,
Solomon Scott D.,
Sabbah Hani N.,
Hinson Andy,
Anker Stefan D.
Publication year - 2016
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.449
Subject(s) - medicine , heart failure , ejection fraction , confidence interval , randomized controlled trial , augment , clinical trial , anaerobic exercise , cardiology , physical therapy , linguistics , philosophy
Aims 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. Methods and 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 VO 2 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 VO 2 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 VO 2 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.