Evidence map›Paper›PMID 26082085›Full record

Trial reportEuropean heart journal2015

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 and 9 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01311791 (A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy), which is not on this map. Cited by 85 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01311791 phase2 / phase3completednot on this map

A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)

TypeinterventionalSponsorLoneStar Heart, Inc.Ran2012 to 2016Enrolled78ConditionsHeart Failure, Dilated CardiomyopathyArmsAlgisyl-LVR, Standard medical therapy
3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  17. Hydrogels for Cardiac Tissue Regeneration: Current and Future Developments.International journal of molecular sciences · 2025
    Review
  18. Review
  19. Article
  20. Article

25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Stefan D AnkerInnovative Clinical Trials, Department of Cardiology and Pneumonology, University Medical Centre Göttingen (UMG), Robert-Koch-Str. 40, Göttingen D-37075, Germany s.anker@cachexia.de.
Andrew J S CoatsMonash University, Melbourne, Australia University of Warwick, Warwick, UK.
Gabriel CristianMilitary Hospital Bucharest, Bucharest, Romania.
Dinu DragomirSpitalul Clinic De Urgenta MAI, Bucharest, Romania.
Enrico PusineriIRCCS San Donato, San Donato Milanese, Italy.
Massimo PireddaIRCCS San Donato, San Donato Milanese, Italy.
Luca BettariIstituti Ospitalieri di Cremona, Cremona, Italy.
Robert DowlingDowling Consulting, Louisville, KY, USA.
Maurizio VolterraniIRCCS San Raffaele, Rome, Italy.
Bridget-Anne KirwanSOCAR Research SA, Nyon, Switzerland.
Gerasimos FilippatosUniversity Hospital Athens, Athens, Greece.
Jean-Louis MasParis Descartes University, Saint-Anne Hospital, Paris, France.
Nicolas DanchinHôpital Européen Georges Pompidou, Paris, France.
Scott D SolomonBrigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Randall J LeeDepartment of Medicine, University of California-San Francisco, San Francisco, CA, USA.
Frank AhmannLoneStar Heart Inc., Laguna Hills, CA, USA.
Andy HinsonLoneStar Heart Inc., Laguna Hills, CA, USA.
Hani N SabbahHenry Ford Health System, Detroit, MI, USA.
Douglas L MannWashington University School of Medicine, Barnes Jewish Hospital, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsAUGMENT-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.

methodsAlginate-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.

resultsEnrolled 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).

conclusionAlginate-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.

Indexed as

AlginatesEchocardiographyExercise TestExercise ToleranceFemaleGlucuronic AcidHeart FailureHexuronic AcidsHumansHydrogel, Polyethylene Glycol DimethacrylateLength of StayMaleMiddle AgedOxygen ConsumptionPatient SafetyProspective StudiesAlginatesGlucuronic AcidHexuronic AcidsHydrogel, Polyethylene Glycol DimethacrylateAdvanced chronic heart failureAlginate-hydrogelExercise capacitySafetySymptoms

Identifiers

PMID26082085
PMCPMC4561351

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.