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Tezosentan in patients with acute heart failure : Design of the value of endothelin receptor inhibition with tezosentan in acute heart failure study (VERITAS)

Identifieur interne : 00A409 ( Main/Exploration ); précédent : 00A408; suivant : 00A410

Tezosentan in patients with acute heart failure : Design of the value of endothelin receptor inhibition with tezosentan in acute heart failure study (VERITAS)

Auteurs : John R. Teerlink [États-Unis] ; John J. V. Mcmurray [Royaume-Uni] ; Robert C. Bourge [États-Unis] ; John G. F. Cleland [Royaume-Uni] ; Gadi Cotter [États-Unis] ; Guillaume Jondeau [France] ; Henry Krum [Australie] ; Marco Metra [Italie] ; Christopher M. O'Connor [États-Unis] ; John D. Parker [Canada] ; Guillermo Torre-Amione [États-Unis] ; Dirk J. Van Veldhuisen [Pays-Bas] ; Aline Frey [Suisse] ; Maurizio Rainisio [Suisse] ; Isaac Kobrin [Suisse]

Source :

RBID : Pascal:05-0391874

Descripteurs français

English descriptors

Abstract

Background Endothelin 1 is a potent endogenous vasoconstrictor neurohormone, and endothelin 1 plasma concentrations predict adverse outcomes in patients with acute heart failure (AHF). Tezosentan, an intravenous endothelin receptor antagonist, improved hemodynamics in patients with AHF; however, its effects on morbidity and mortality have not been evaluated. Methods The VERITAS program consists of 2 identical, double-blind, randomized, placebo-controlled, concurrently conducted trials (VERITAS-1 and VERITAS-2), performed in 150 centers in Europe, Israel, Australia, and North America. The program is designed to enroll at least 1760 patients hospitalized with dyspnea at rest because of AHF requiring intravenous therapy. In addition to conventional therapy, patients are randomized to receive tezosentan (5 mg/h for 30 minutes, then 1 mg/h for 24-72 hours) or matching placebo. The 2 prespecified primary end points are the incidence of death or worsening heart failure at 7 days in the combined studies and the change from baseline in dyspnea over the first 24 hours of treatment, measured using a visual analog scale in VERITAS-1 and VERITAS-2, individually. Results Enrollment started in April 2003, and the program was discontinued in November 2005 because of the low probability of achieving a significant treatment effect. Conclusions No currently available agents have been shown in a prospective, randomized, clinical trial to improve outcomes in patients with AHF. Thus, the VERITAS program will provide valuable insights into the effect of tezosentan on clinical outcomes in patients with AHF, as well as hemodynamics and clinical symptoms.


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Le document en format XML

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<term>Acute</term>
<term>Biological receptor</term>
<term>Cardiology</term>
<term>Circulatory system</term>
<term>Design</term>
<term>Endothelin</term>
<term>Heart failure</term>
<term>Human</term>
<term>Inhibition</term>
<term>Phlebology</term>
<term>Tezosentan</term>
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<term>Insuffisance cardiaque</term>
<term>Tézosentan</term>
<term>Homme</term>
<term>Aigu</term>
<term>Conception</term>
<term>Endothéline</term>
<term>Récepteur biologique</term>
<term>Inhibition</term>
<term>Appareil circulatoire</term>
<term>Cardiologie</term>
<term>Phlébologie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Background Endothelin 1 is a potent endogenous vasoconstrictor neurohormone, and endothelin 1 plasma concentrations predict adverse outcomes in patients with acute heart failure (AHF). Tezosentan, an intravenous endothelin receptor antagonist, improved hemodynamics in patients with AHF; however, its effects on morbidity and mortality have not been evaluated. Methods The VERITAS program consists of 2 identical, double-blind, randomized, placebo-controlled, concurrently conducted trials (VERITAS-1 and VERITAS-2), performed in 150 centers in Europe, Israel, Australia, and North America. The program is designed to enroll at least 1760 patients hospitalized with dyspnea at rest because of AHF requiring intravenous therapy. In addition to conventional therapy, patients are randomized to receive tezosentan (5 mg/h for 30 minutes, then 1 mg/h for 24-72 hours) or matching placebo. The 2 prespecified primary end points are the incidence of death or worsening heart failure at 7 days in the combined studies and the change from baseline in dyspnea over the first 24 hours of treatment, measured using a visual analog scale in VERITAS-1 and VERITAS-2, individually. Results Enrollment started in April 2003, and the program was discontinued in November 2005 because of the low probability of achieving a significant treatment effect. Conclusions No currently available agents have been shown in a prospective, randomized, clinical trial to improve outcomes in patients with AHF. Thus, the VERITAS program will provide valuable insights into the effect of tezosentan on clinical outcomes in patients with AHF, as well as hemodynamics and clinical symptoms.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
<li>Californie</li>
<li>Groningue (province)</li>
<li>Texas</li>
<li>Écosse</li>
</region>
<settlement>
<li>Glasgow</li>
<li>Groningue</li>
<li>Houston</li>
<li>San Francisco</li>
</settlement>
<orgName>
<li>Baylor College of Medicine</li>
<li>Université de Glasgow</li>
</orgName>
</list>
<tree>
<country name="États-Unis">
<region name="Californie">
<name sortKey="Teerlink, John R" sort="Teerlink, John R" uniqKey="Teerlink J" first="John R." last="Teerlink">John R. Teerlink</name>
</region>
<name sortKey="Bourge, Robert C" sort="Bourge, Robert C" uniqKey="Bourge R" first="Robert C." last="Bourge">Robert C. Bourge</name>
<name sortKey="Cotter, Gadi" sort="Cotter, Gadi" uniqKey="Cotter G" first="Gadi" last="Cotter">Gadi Cotter</name>
<name sortKey="O Connor, Christopher M" sort="O Connor, Christopher M" uniqKey="O Connor C" first="Christopher M." last="O'Connor">Christopher M. O'Connor</name>
<name sortKey="Torre Amione, Guillermo" sort="Torre Amione, Guillermo" uniqKey="Torre Amione G" first="Guillermo" last="Torre-Amione">Guillermo Torre-Amione</name>
</country>
<country name="Royaume-Uni">
<region name="Écosse">
<name sortKey="Mcmurray, John J V" sort="Mcmurray, John J V" uniqKey="Mcmurray J" first="John J. V." last="Mcmurray">John J. V. Mcmurray</name>
</region>
<name sortKey="Cleland, John G F" sort="Cleland, John G F" uniqKey="Cleland J" first="John G. F." last="Cleland">John G. F. Cleland</name>
</country>
<country name="France">
<noRegion>
<name sortKey="Jondeau, Guillaume" sort="Jondeau, Guillaume" uniqKey="Jondeau G" first="Guillaume" last="Jondeau">Guillaume Jondeau</name>
</noRegion>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name>
</noRegion>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Metra, Marco" sort="Metra, Marco" uniqKey="Metra M" first="Marco" last="Metra">Marco Metra</name>
</noRegion>
</country>
<country name="Canada">
<noRegion>
<name sortKey="Parker, John D" sort="Parker, John D" uniqKey="Parker J" first="John D." last="Parker">John D. Parker</name>
</noRegion>
</country>
<country name="Pays-Bas">
<region name="Groningue (province)">
<name sortKey="Van Veldhuisen, Dirk J" sort="Van Veldhuisen, Dirk J" uniqKey="Van Veldhuisen D" first="Dirk J." last="Van Veldhuisen">Dirk J. Van Veldhuisen</name>
</region>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Frey, Aline" sort="Frey, Aline" uniqKey="Frey A" first="Aline" last="Frey">Aline Frey</name>
</noRegion>
<name sortKey="Kobrin, Isaac" sort="Kobrin, Isaac" uniqKey="Kobrin I" first="Isaac" last="Kobrin">Isaac Kobrin</name>
<name sortKey="Rainisio, Maurizio" sort="Rainisio, Maurizio" uniqKey="Rainisio M" first="Maurizio" last="Rainisio">Maurizio Rainisio</name>
</country>
</tree>
</affiliations>
</record>

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