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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)

Identifieur interne : 003232 ( Main/Exploration ); précédent : 003231; suivant : 003233

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)

Auteurs : Stefan D. Anker [Allemagne] ; Andrew J. S. Coats [Australie, Royaume-Uni] ; Gabriel Cristian [Roumanie] ; Dinu Dragomir [Roumanie] ; Enrico Pusineri [Italie] ; Massimo Piredda [Italie] ; Luca Bettari [Italie] ; Robert Dowling [États-Unis] ; Maurizio Volterrani [Italie] ; Bridget-Anne Kirwan [Suisse] ; Gerasimos Filippatos [Grèce] ; Jean-Louis Mas [France] ; Nicolas Danchin [France] ; Scott D. Solomon [États-Unis] ; Randall J. Lee [États-Unis] ; Frank Ahmann [États-Unis] ; Andy Hinson [États-Unis] ; Hani N. Sabbah [États-Unis] ; Douglas L. Mann [États-Unis]

Source :

RBID : PMC:4561351

Descripteurs français

English descriptors

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.


Url:
DOI: 10.1093/eurheartj/ehv259
PubMed: 26082085
PubMed Central: 4561351


Affiliations:


Links toward previous steps (curation, corpus...)


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<title xml:lang="en" level="a" type="main">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)</title>
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<name sortKey="Anker, Stefan D" sort="Anker, Stefan D" uniqKey="Anker S" first="Stefan D." last="Anker">Stefan D. Anker</name>
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<addr-line>Innovative Clinical Trials, Department of Cardiology and Pneumonology</addr-line>
,
<institution>University Medical Centre Göttingen (UMG)</institution>
,
<addr-line>Robert-Koch-Str. 40, Göttingen D-37075</addr-line>
,
<country>Germany</country>
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<country xml:lang="fr">Allemagne</country>
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<name sortKey="Bettari, Luca" sort="Bettari, Luca" uniqKey="Bettari L" first="Luca" last="Bettari">Luca Bettari</name>
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<name sortKey="Dowling, Robert" sort="Dowling, Robert" uniqKey="Dowling R" first="Robert" last="Dowling">Robert Dowling</name>
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<addr-line>Louisville, KY</addr-line>
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<name sortKey="Volterrani, Maurizio" sort="Volterrani, Maurizio" uniqKey="Volterrani M" first="Maurizio" last="Volterrani">Maurizio Volterrani</name>
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<addr-line>Rome</addr-line>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Kirwan, Bridget Anne" sort="Kirwan, Bridget Anne" uniqKey="Kirwan B" first="Bridget-Anne" last="Kirwan">Bridget-Anne Kirwan</name>
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<institution>SOCAR Research SA</institution>
,
<addr-line>Nyon</addr-line>
,
<country>Switzerland</country>
</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name>
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<institution>University Hospital Athens</institution>
,
<addr-line>Athens</addr-line>
,
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</nlm:aff>
<country xml:lang="fr">Grèce</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Mas, Jean Louis" sort="Mas, Jean Louis" uniqKey="Mas J" first="Jean-Louis" last="Mas">Jean-Louis Mas</name>
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<institution>Paris Descartes University, Saint-Anne Hospital</institution>
,
<addr-line>Paris</addr-line>
,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<name sortKey="Danchin, Nicolas" sort="Danchin, Nicolas" uniqKey="Danchin N" first="Nicolas" last="Danchin">Nicolas Danchin</name>
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<nlm:aff id="af13">
<institution>Hôpital Européen Georges Pompidou</institution>
,
<addr-line>Paris</addr-line>
,
<country>France</country>
</nlm:aff>
<country xml:lang="fr">France</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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</author>
<author>
<name sortKey="Solomon, Scott D" sort="Solomon, Scott D" uniqKey="Solomon S" first="Scott D." last="Solomon">Scott D. Solomon</name>
<affiliation wicri:level="1">
<nlm:aff id="af14">
<institution>Brigham and Women's Hospital and Harvard Medical School</institution>
,
<addr-line>Boston, MA</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Lee, Randall J" sort="Lee, Randall J" uniqKey="Lee R" first="Randall J." last="Lee">Randall J. Lee</name>
<affiliation wicri:level="1">
<nlm:aff id="af15">
<addr-line>Department of Medicine</addr-line>
,
<institution>University of California-San Francisco</institution>
,
<addr-line>San Francisco, CA</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Ahmann, Frank" sort="Ahmann, Frank" uniqKey="Ahmann F" first="Frank" last="Ahmann">Frank Ahmann</name>
<affiliation wicri:level="1">
<nlm:aff id="af16">
<institution>LoneStar Heart Inc.</institution>
,
<addr-line>Laguna Hills, CA</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Hinson, Andy" sort="Hinson, Andy" uniqKey="Hinson A" first="Andy" last="Hinson">Andy Hinson</name>
<affiliation wicri:level="1">
<nlm:aff id="af16">
<institution>LoneStar Heart Inc.</institution>
,
<addr-line>Laguna Hills, CA</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Sabbah, Hani N" sort="Sabbah, Hani N" uniqKey="Sabbah H" first="Hani N." last="Sabbah">Hani N. Sabbah</name>
<affiliation wicri:level="1">
<nlm:aff id="af17">
<institution>Henry Ford Health System</institution>
,
<addr-line>Detroit, MI</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author>
<name sortKey="Mann, Douglas L" sort="Mann, Douglas L" uniqKey="Mann D" first="Douglas L." last="Mann">Douglas L. Mann</name>
<affiliation wicri:level="1">
<nlm:aff id="af18">
<institution>Washington University School of Medicine, Barnes Jewish Hospital</institution>
,
<addr-line>St. Louis, MO</addr-line>
,
<country>USA</country>
</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series>
<title level="j">European Heart Journal</title>
<idno type="ISSN">0195-668X</idno>
<idno type="eISSN">1522-9645</idno>
<imprint>
<date when="2015">2015</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Alginates (administration & dosage)</term>
<term>Echocardiography</term>
<term>Exercise Test</term>
<term>Exercise Tolerance (physiology)</term>
<term>Female</term>
<term>Glucuronic Acid (administration & dosage)</term>
<term>Heart Failure (physiopathology)</term>
<term>Heart Failure (therapy)</term>
<term>Hexuronic Acids (administration & dosage)</term>
<term>Humans</term>
<term>Hydrogel (administration & dosage)</term>
<term>Length of Stay</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Oxygen Consumption (physiology)</term>
<term>Patient Safety</term>
<term>Prospective Studies</term>
<term>Prostheses and Implants</term>
<term>Quality of Life</term>
<term>Treatment Outcome</term>
<term>Walking (physiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Acide glucuronique (administration et posologie)</term>
<term>Acides hexuroniques (administration et posologie)</term>
<term>Adulte d'âge moyen</term>
<term>Alginates (administration et posologie)</term>
<term>Consommation d'oxygène (physiologie)</term>
<term>Durée du séjour</term>
<term>Défaillance cardiaque ()</term>
<term>Défaillance cardiaque (physiopathologie)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hydrogel (administration et posologie)</term>
<term>Marche à pied (physiologie)</term>
<term>Mâle</term>
<term>Prothèses et implants</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Sécurité des patients</term>
<term>Tolérance à l'effort (physiologie)</term>
<term>Échocardiographie</term>
<term>Épreuve d'effort</term>
<term>Études prospectives</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Alginates</term>
<term>Glucuronic Acid</term>
<term>Hexuronic Acids</term>
<term>Hydrogel</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr">
<term>Acide glucuronique</term>
<term>Acides hexuroniques</term>
<term>Alginates</term>
<term>Hydrogel</term>
</keywords>
<keywords scheme="MESH" qualifier="physiologie" xml:lang="fr">
<term>Consommation d'oxygène</term>
<term>Marche à pied</term>
<term>Tolérance à l'effort</term>
</keywords>
<keywords scheme="MESH" qualifier="physiology" xml:lang="en">
<term>Exercise Tolerance</term>
<term>Oxygen Consumption</term>
<term>Walking</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr">
<term>Défaillance cardiaque</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en">
<term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Heart Failure</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Echocardiography</term>
<term>Exercise Test</term>
<term>Female</term>
<term>Humans</term>
<term>Length of Stay</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Patient Safety</term>
<term>Prospective Studies</term>
<term>Prostheses and Implants</term>
<term>Quality of Life</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte d'âge moyen</term>
<term>Durée du séjour</term>
<term>Défaillance cardiaque</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Prothèses et implants</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>Sécurité des patients</term>
<term>Échocardiographie</term>
<term>Épreuve d'effort</term>
<term>Études prospectives</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Aims</title>
<p>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.</p>
</sec>
<sec>
<title>Methods</title>
<p>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 (
<italic>n</italic>
= 40) in combination with standard medical therapy or standard medical therapy alone (Control,
<italic>n</italic>
= 38). The primary endpoint of AUGMENT-HF was the change in peak VO
<sub>2</sub>
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.</p>
</sec>
<sec>
<title>Results</title>
<p>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 VO
<sub>2</sub>
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 VO
<sub>2</sub>
at 6 months—treatment effect vs. Control: +1.24 mL/kg/min (95% confidence interval 0.26–2.23,
<italic>P</italic>
= 0.014). Also 6MWT distance and NYHA functional class improved in alginate-hydrogel-treated patients vs. Control (both
<italic>P</italic>
< 0.001).</p>
</sec>
<sec>
<title>Conclusion</title>
<p>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.</p>
</sec>
<sec>
<title>Trial Registration Number</title>
<p>NCT01311791.</p>
</sec>
</div>
</front>
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