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

Douglas L. Mann, Randall J. Lee, Andrew J.S. Coats, Gheorghe Neagoe, Dinu Dragomir, Enrico Pusineri, Massimo Piredda, Luca Bettari, Bridget Anne Kirwan, Robert Dowling, Maurizio Volterrani, Scott D. Solomon, Hani N. Sabbah, Andy Hinson, Stefan D. Anker

Research output: Contribution to journalArticle

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Abstract

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 VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m2 (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.

Original languageEnglish (US)
Pages (from-to)314-325
Number of pages12
JournalEuropean Journal of Heart Failure
Volume18
Issue number3
DOIs
StatePublished - Mar 1 2016

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Treatment Failure
Randomized Controlled Trials
Heart Failure
Therapeutics
Anaerobic Threshold
Hydrogel
Body Surface Area
Clinical Trials
Confidence Intervals
Exercise
Control Groups
Injections

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Mann, Douglas L. ; Lee, Randall J. ; Coats, Andrew J.S. ; Neagoe, Gheorghe ; Dragomir, Dinu ; Pusineri, Enrico ; Piredda, Massimo ; Bettari, Luca ; Kirwan, Bridget Anne ; Dowling, Robert ; Volterrani, Maurizio ; Solomon, Scott D. ; Sabbah, Hani N. ; Hinson, Andy ; Anker, Stefan D. / 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. In: European Journal of Heart Failure. 2016 ; Vol. 18, No. 3. pp. 314-325.
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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 = "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 VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m2 (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.",
author = "Mann, {Douglas L.} and Lee, {Randall J.} and Coats, {Andrew J.S.} and Gheorghe Neagoe and Dinu Dragomir and Enrico Pusineri and Massimo Piredda and Luca Bettari and Kirwan, {Bridget Anne} and Robert Dowling and Maurizio Volterrani and Solomon, {Scott D.} and Sabbah, {Hani N.} and Andy Hinson and Anker, {Stefan D.}",
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Mann, DL, Lee, RJ, Coats, AJS, Neagoe, G, Dragomir, D, Pusineri, E, Piredda, M, Bettari, L, Kirwan, BA, Dowling, R, Volterrani, M, Solomon, SD, Sabbah, HN, Hinson, A & Anker, SD 2016, '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', European Journal of Heart Failure, vol. 18, no. 3, pp. 314-325. https://doi.org/10.1002/ejhf.449

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. / Mann, Douglas L.; Lee, Randall J.; Coats, Andrew J.S.; Neagoe, Gheorghe; Dragomir, Dinu; Pusineri, Enrico; Piredda, Massimo; Bettari, Luca; Kirwan, Bridget Anne; Dowling, Robert; Volterrani, Maurizio; Solomon, Scott D.; Sabbah, Hani N.; Hinson, Andy; Anker, Stefan D.

In: European Journal of Heart Failure, Vol. 18, No. 3, 01.03.2016, p. 314-325.

Research output: Contribution to journalArticle

TY - JOUR

T1 - One-year follow-up results from AUGMENT-HF

T2 - A multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure

AU - Mann, Douglas L.

AU - Lee, Randall J.

AU - Coats, Andrew J.S.

AU - Neagoe, Gheorghe

AU - Dragomir, Dinu

AU - Pusineri, Enrico

AU - Piredda, Massimo

AU - Bettari, Luca

AU - Kirwan, Bridget Anne

AU - Dowling, Robert

AU - Volterrani, Maurizio

AU - Solomon, Scott D.

AU - Sabbah, Hani N.

AU - Hinson, Andy

AU - Anker, Stefan D.

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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 VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m2 (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.

AB - 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 VO2 of 9.0-14.5 mL/min/kg and LV end-diastolic diameter (LVEDD) index 30-40 mm/m2 (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.

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