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)

Stefan D. Anker, Andrew J.S. Coats, Gabriel Cristian, Dinu Dragomir, Enrico Pusineri, Massimo Piredda, Luca Bettari, Robert Dowling, Maurizio Volterrani, Bridget Anne Kirwan, Gerasimos Filippatos, Jean Louis Mas, Nicolas Danchin, Scott D. Solomon, Randall J. Lee, Frank Ahmann, Andy Hinson, Hani N. Sabbah, Douglas L. Mann

Research output: Contribution to journalArticle

65 Scopus citations

Abstract

Aims 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. Control: +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). Conclusion 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. Trial Registration Number NCT01311791.

Original languageEnglish (US)
Pages (from-to)2297-2309
Number of pages13
JournalEuropean Heart Journal
Volume36
Issue number34
DOIs
StatePublished - Sep 7 2015

    Fingerprint

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Anker, S. D., Coats, A. J. S., Cristian, G., Dragomir, D., Pusineri, E., Piredda, M., Bettari, L., Dowling, R., Volterrani, M., Kirwan, B. A., Filippatos, G., Mas, J. L., Danchin, N., Solomon, S. D., Lee, R. J., Ahmann, F., Hinson, A., Sabbah, H. N., & Mann, D. L. (2015). 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). European Heart Journal, 36(34), 2297-2309. https://doi.org/10.1093/eurheartj/ehv259