PMID- 26082085 OWN - NLM STAT- MEDLINE DCOM- 20160620 LR - 20220410 IS - 1522-9645 (Electronic) IS - 0195-668X (Print) IS - 0195-668X (Linking) VI - 36 IP - 34 DP - 2015 Sep 7 TI - 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). PG - 2297-309 LID - 10.1093/eurheartj/ehv259 [doi] AB - 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. CI - (c) The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology. FAU - Anker, Stefan D AU - Anker SD AD - Innovative Clinical Trials, Department of Cardiology and Pneumonology, University Medical Centre Gottingen (UMG), Robert-Koch-Str. 40, Gottingen D-37075, Germany s.anker@cachexia.de. FAU - Coats, Andrew J S AU - Coats AJ AD - Monash University, Melbourne, Australia University of Warwick, Warwick, UK. FAU - Cristian, Gabriel AU - Cristian G AD - Military Hospital Bucharest, Bucharest, Romania. FAU - Dragomir, Dinu AU - Dragomir D AD - Spitalul Clinic De Urgenta MAI, Bucharest, Romania. FAU - Pusineri, Enrico AU - Pusineri E AD - IRCCS San Donato, San Donato Milanese, Italy. FAU - Piredda, Massimo AU - Piredda M AD - IRCCS San Donato, San Donato Milanese, Italy. FAU - Bettari, Luca AU - Bettari L AD - Istituti Ospitalieri di Cremona, Cremona, Italy. FAU - Dowling, Robert AU - Dowling R AD - Dowling Consulting, Louisville, KY, USA. FAU - Volterrani, Maurizio AU - Volterrani M AD - IRCCS San Raffaele, Rome, Italy. FAU - Kirwan, Bridget-Anne AU - Kirwan BA AD - SOCAR Research SA, Nyon, Switzerland. FAU - Filippatos, Gerasimos AU - Filippatos G AD - University Hospital Athens, Athens, Greece. FAU - Mas, Jean-Louis AU - Mas JL AD - Paris Descartes University, Saint-Anne Hospital, Paris, France. FAU - Danchin, Nicolas AU - Danchin N AD - Hopital Europeen Georges Pompidou, Paris, France. FAU - Solomon, Scott D AU - Solomon SD AD - Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. FAU - Lee, Randall J AU - Lee RJ AD - Department of Medicine, University of California-San Francisco, San Francisco, CA, USA. FAU - Ahmann, Frank AU - Ahmann F AD - LoneStar Heart Inc., Laguna Hills, CA, USA. FAU - Hinson, Andy AU - Hinson A AD - LoneStar Heart Inc., Laguna Hills, CA, USA. FAU - Sabbah, Hani N AU - Sabbah HN AD - Henry Ford Health System, Detroit, MI, USA. FAU - Mann, Douglas L AU - Mann DL AD - Washington University School of Medicine, Barnes Jewish Hospital, St. Louis, MO, USA. LA - eng SI - ClinicalTrials.gov/NCT01311791 PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150616 PL - England TA - Eur Heart J JT - European heart journal JID - 8006263 RN - 0 (Alginates) RN - 0 (Hexuronic Acids) RN - 25852-47-5 (Hydrogel, Polyethylene Glycol Dimethacrylate) RN - 8A5D83Q4RW (Glucuronic Acid) SB - IM CIN - Eur Heart J. 2015 Sep 7;36(34):2276-8. PMID: 26093637 CIN - Nat Rev Cardiol. 2015 Aug;12(8):443. PMID: 26149488 MH - Alginates/*administration & dosage MH - Echocardiography MH - Exercise Test MH - Exercise Tolerance/physiology MH - Female MH - Glucuronic Acid/administration & dosage MH - Heart Failure/physiopathology/*therapy MH - Hexuronic Acids/administration & dosage MH - Humans MH - Hydrogel, Polyethylene Glycol Dimethacrylate/*administration & dosage MH - Length of Stay MH - Male MH - Middle Aged MH - Oxygen Consumption/physiology MH - Patient Safety MH - Prospective Studies MH - Prostheses and Implants MH - Quality of Life MH - Treatment Outcome MH - Walking/physiology PMC - PMC4561351 OTO - NOTNLM OT - Advanced chronic heart failure OT - Alginate-hydrogel OT - Exercise capacity OT - Safety OT - Symptoms EDAT- 2015/06/18 06:00 MHDA- 2016/06/21 06:00 PMCR- 2015/06/16 CRDT- 2015/06/18 06:00 PHST- 2015/04/30 00:00 [received] PHST- 2015/05/21 00:00 [accepted] PHST- 2015/06/18 06:00 [entrez] PHST- 2015/06/18 06:00 [pubmed] PHST- 2016/06/21 06:00 [medline] PHST- 2015/06/16 00:00 [pmc-release] AID - ehv259 [pii] AID - 10.1093/eurheartj/ehv259 [doi] PST - ppublish SO - Eur Heart J. 2015 Sep 7;36(34):2297-309. doi: 10.1093/eurheartj/ehv259. Epub 2015 Jun 16.