Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial
Urodilatin (ularitide), a natriuretic peptide, is produced within the kidneys. The aim of this study was to define the role of 24-hour intravenous infusions of urodilatin in the treatment of decompensated chronic heart failure (DHF). In this randomized, double-blind, ascending-dose safety study, 24...
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| Veröffentlicht in: | The American heart journal 2005-12, Vol.150 (6), p.1239.e1-1239.e8 |
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| creator | Mitrovic, Veselin Lüss, Hartmut Nitsche, Klaus Forssmann, Kristin Maronde, Erik Fricke, Katrin Forssmann, Wolf-Georg Meyer, Markus |
| description | Urodilatin (ularitide), a natriuretic peptide, is produced within the kidneys. The aim of this study was to define the role of 24-hour intravenous infusions of urodilatin in the treatment of decompensated chronic heart failure (DHF).
In this randomized, double-blind, ascending-dose safety study, 24 patients with DHF (cardiac index 1.91 ± 0.34 L/min per square meter, pulmonary capillary wedge pressure 26 ± 6 mm Hg, right atrial pressure 11 ± 4 mm Hg) received urodilatin (7.5, 15, or 30 ng/(kg · min)) or placebo infusions over 24 hours.
Compared with baseline, urodilatin decreased pulmonary capillary wedge pressure by 10 mm Hg in the 15 ng/(kg · min) group (
P < .05) and by 15 mm Hg in the 30 ng/(kg · min) group (
P < .05) at 6 hours. In the same dose groups, right atrial pressure decreased, and dyspnea as reported by patients tended to improve. At 24 hours, 15 and 30 ng/(kg · min) urodilatin infusions decreased N-terminal–pro–brain natriuretic peptide levels by 40% and 45%, respectively, compared with baseline. Between 1 to 12 hours, plasma cyclic guanosine monophosphate levels at 15 and 30 ng/(kg · min) urodilatin were significantly higher than both placebo and the respective baseline after infusion start (
P < .05 and .01). Among the different groups, there was no obvious difference regarding total number of patients with adverse events and total number of adverse events. During infusion, 3 transient asymptomatic hypotensions occurred in the urodilatin groups.
Our findings show that urodilatin may be a new agent for the therapy for DHF. |
| doi_str_mv | 10.1016/j.ahj.2005.01.022 |
| format | Article |
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In this randomized, double-blind, ascending-dose safety study, 24 patients with DHF (cardiac index 1.91 ± 0.34 L/min per square meter, pulmonary capillary wedge pressure 26 ± 6 mm Hg, right atrial pressure 11 ± 4 mm Hg) received urodilatin (7.5, 15, or 30 ng/(kg · min)) or placebo infusions over 24 hours.
Compared with baseline, urodilatin decreased pulmonary capillary wedge pressure by 10 mm Hg in the 15 ng/(kg · min) group (
P < .05) and by 15 mm Hg in the 30 ng/(kg · min) group (
P < .05) at 6 hours. In the same dose groups, right atrial pressure decreased, and dyspnea as reported by patients tended to improve. At 24 hours, 15 and 30 ng/(kg · min) urodilatin infusions decreased N-terminal–pro–brain natriuretic peptide levels by 40% and 45%, respectively, compared with baseline. Between 1 to 12 hours, plasma cyclic guanosine monophosphate levels at 15 and 30 ng/(kg · min) urodilatin were significantly higher than both placebo and the respective baseline after infusion start (
P < .05 and .01). Among the different groups, there was no obvious difference regarding total number of patients with adverse events and total number of adverse events. During infusion, 3 transient asymptomatic hypotensions occurred in the urodilatin groups.
Our findings show that urodilatin may be a new agent for the therapy for DHF.</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2005.01.022</identifier><identifier>PMID: 16338265</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Mosby, Inc</publisher><subject>Aged ; Aqueous solutions ; Atrial Natriuretic Factor - pharmacology ; Blood pressure ; Chronic Disease ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug dosages ; Drug therapy ; Female ; Heart failure ; Heart Failure - metabolism ; Heart Function Tests ; Heart rate ; Humans ; Intubation ; ISDN ; Kidney - metabolism ; Male ; Middle Aged ; Patient Selection ; Peptide Fragments - pharmacology ; Peptides ; Placebos ; Respiratory Function Tests ; Rodents</subject><ispartof>The American heart journal, 2005-12, Vol.150 (6), p.1239.e1-1239.e8</ispartof><rights>2005 Mosby, Inc.</rights><rights>Copyright Elsevier Limited Dec 2005</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c379t-2da94a92ef3447b6aa2a1fbe7192d2fa3b4c352a4e65b75e0b70e85221e1d8843</citedby><cites>FETCH-LOGICAL-c379t-2da94a92ef3447b6aa2a1fbe7192d2fa3b4c352a4e65b75e0b70e85221e1d8843</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1504621305?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/16338265$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mitrovic, Veselin</creatorcontrib><creatorcontrib>Lüss, Hartmut</creatorcontrib><creatorcontrib>Nitsche, Klaus</creatorcontrib><creatorcontrib>Forssmann, Kristin</creatorcontrib><creatorcontrib>Maronde, Erik</creatorcontrib><creatorcontrib>Fricke, Katrin</creatorcontrib><creatorcontrib>Forssmann, Wolf-Georg</creatorcontrib><creatorcontrib>Meyer, Markus</creatorcontrib><title>Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Urodilatin (ularitide), a natriuretic peptide, is produced within the kidneys. The aim of this study was to define the role of 24-hour intravenous infusions of urodilatin in the treatment of decompensated chronic heart failure (DHF).
In this randomized, double-blind, ascending-dose safety study, 24 patients with DHF (cardiac index 1.91 ± 0.34 L/min per square meter, pulmonary capillary wedge pressure 26 ± 6 mm Hg, right atrial pressure 11 ± 4 mm Hg) received urodilatin (7.5, 15, or 30 ng/(kg · min)) or placebo infusions over 24 hours.
Compared with baseline, urodilatin decreased pulmonary capillary wedge pressure by 10 mm Hg in the 15 ng/(kg · min) group (
P < .05) and by 15 mm Hg in the 30 ng/(kg · min) group (
P < .05) at 6 hours. In the same dose groups, right atrial pressure decreased, and dyspnea as reported by patients tended to improve. At 24 hours, 15 and 30 ng/(kg · min) urodilatin infusions decreased N-terminal–pro–brain natriuretic peptide levels by 40% and 45%, respectively, compared with baseline. Between 1 to 12 hours, plasma cyclic guanosine monophosphate levels at 15 and 30 ng/(kg · min) urodilatin were significantly higher than both placebo and the respective baseline after infusion start (
P < .05 and .01). Among the different groups, there was no obvious difference regarding total number of patients with adverse events and total number of adverse events. During infusion, 3 transient asymptomatic hypotensions occurred in the urodilatin groups.
Our findings show that urodilatin may be a new agent for the therapy for DHF.</description><subject>Aged</subject><subject>Aqueous solutions</subject><subject>Atrial Natriuretic Factor - pharmacology</subject><subject>Blood pressure</subject><subject>Chronic Disease</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug dosages</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Heart failure</subject><subject>Heart Failure - metabolism</subject><subject>Heart Function Tests</subject><subject>Heart rate</subject><subject>Humans</subject><subject>Intubation</subject><subject>ISDN</subject><subject>Kidney - metabolism</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Patient Selection</subject><subject>Peptide Fragments - pharmacology</subject><subject>Peptides</subject><subject>Placebos</subject><subject>Respiratory Function Tests</subject><subject>Rodents</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kd-K1TAQh4Mo7tnVB_BGAoKsYGuStmmrV8uy_oEFb_Q6TJOpzSEnqUmq-FI-ozmcA4IXXg0zfPNjmI-QZ5zVnHH5Zl_Dsq8FY13NeM2EeEB2nI19Jfu2fUh2jDFRDT1rLshlSvvSSjHIx-SCy6YZhOx25PfdPKPOiYaZ5gVpRA-OesjRbhGz1XTFNVuDdIvBWAfZenq9OYj2OH1FS7uWIfqS8dPmhRrU4bCiT5DRUL3E4EvKghAzncG6EvuW3lATtslhNTnrzWu6OtA4hUoHn2NwDssMkkZvrP9WmZCQlovAPSGPZnAJn57rFfn6_u7L7cfq_vOHT7c395Vu-jFXwsDYwihwbtq2nySAAD5P2PNRGDFDM7W66QS0KLup75BNPcOhE4IjN8PQNlfk5Sl3jeH7himrgy3nOAcew5aUHIZBsp4X8MU_4D5ssfwwKd6xVgresK5Q_ETpGFKKOKs12gPEX4ozdVSp9qqoVEeVinFVVJad5-fkbTqg-btxdleAdycAyyN-WIwq6eJBo7GxKFUm2P_E_wFNiLG7</recordid><startdate>20051201</startdate><enddate>20051201</enddate><creator>Mitrovic, Veselin</creator><creator>Lüss, Hartmut</creator><creator>Nitsche, Klaus</creator><creator>Forssmann, Kristin</creator><creator>Maronde, Erik</creator><creator>Fricke, Katrin</creator><creator>Forssmann, Wolf-Georg</creator><creator>Meyer, Markus</creator><general>Mosby, Inc</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20051201</creationdate><title>Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial</title><author>Mitrovic, Veselin ; Lüss, Hartmut ; Nitsche, Klaus ; Forssmann, Kristin ; Maronde, Erik ; Fricke, Katrin ; Forssmann, Wolf-Georg ; Meyer, Markus</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c379t-2da94a92ef3447b6aa2a1fbe7192d2fa3b4c352a4e65b75e0b70e85221e1d8843</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Aged</topic><topic>Aqueous solutions</topic><topic>Atrial Natriuretic Factor - pharmacology</topic><topic>Blood pressure</topic><topic>Chronic Disease</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug dosages</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Heart failure</topic><topic>Heart Failure - metabolism</topic><topic>Heart Function Tests</topic><topic>Heart rate</topic><topic>Humans</topic><topic>Intubation</topic><topic>ISDN</topic><topic>Kidney - metabolism</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Patient Selection</topic><topic>Peptide Fragments - pharmacology</topic><topic>Peptides</topic><topic>Placebos</topic><topic>Respiratory Function Tests</topic><topic>Rodents</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mitrovic, Veselin</creatorcontrib><creatorcontrib>Lüss, Hartmut</creatorcontrib><creatorcontrib>Nitsche, Klaus</creatorcontrib><creatorcontrib>Forssmann, Kristin</creatorcontrib><creatorcontrib>Maronde, Erik</creatorcontrib><creatorcontrib>Fricke, Katrin</creatorcontrib><creatorcontrib>Forssmann, Wolf-Georg</creatorcontrib><creatorcontrib>Meyer, Markus</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mitrovic, Veselin</au><au>Lüss, Hartmut</au><au>Nitsche, Klaus</au><au>Forssmann, Kristin</au><au>Maronde, Erik</au><au>Fricke, Katrin</au><au>Forssmann, Wolf-Georg</au><au>Meyer, Markus</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2005-12-01</date><risdate>2005</risdate><volume>150</volume><issue>6</issue><spage>1239.e1</spage><epage>1239.e8</epage><pages>1239.e1-1239.e8</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Urodilatin (ularitide), a natriuretic peptide, is produced within the kidneys. The aim of this study was to define the role of 24-hour intravenous infusions of urodilatin in the treatment of decompensated chronic heart failure (DHF).
In this randomized, double-blind, ascending-dose safety study, 24 patients with DHF (cardiac index 1.91 ± 0.34 L/min per square meter, pulmonary capillary wedge pressure 26 ± 6 mm Hg, right atrial pressure 11 ± 4 mm Hg) received urodilatin (7.5, 15, or 30 ng/(kg · min)) or placebo infusions over 24 hours.
Compared with baseline, urodilatin decreased pulmonary capillary wedge pressure by 10 mm Hg in the 15 ng/(kg · min) group (
P < .05) and by 15 mm Hg in the 30 ng/(kg · min) group (
P < .05) at 6 hours. In the same dose groups, right atrial pressure decreased, and dyspnea as reported by patients tended to improve. At 24 hours, 15 and 30 ng/(kg · min) urodilatin infusions decreased N-terminal–pro–brain natriuretic peptide levels by 40% and 45%, respectively, compared with baseline. Between 1 to 12 hours, plasma cyclic guanosine monophosphate levels at 15 and 30 ng/(kg · min) urodilatin were significantly higher than both placebo and the respective baseline after infusion start (
P < .05 and .01). Among the different groups, there was no obvious difference regarding total number of patients with adverse events and total number of adverse events. During infusion, 3 transient asymptomatic hypotensions occurred in the urodilatin groups.
Our findings show that urodilatin may be a new agent for the therapy for DHF.</abstract><cop>United States</cop><pub>Mosby, Inc</pub><pmid>16338265</pmid><doi>10.1016/j.ahj.2005.01.022</doi><tpages>1</tpages></addata></record> |
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| subjects | Aged Aqueous solutions Atrial Natriuretic Factor - pharmacology Blood pressure Chronic Disease Dose-Response Relationship, Drug Double-Blind Method Drug dosages Drug therapy Female Heart failure Heart Failure - metabolism Heart Function Tests Heart rate Humans Intubation ISDN Kidney - metabolism Male Middle Aged Patient Selection Peptide Fragments - pharmacology Peptides Placebos Respiratory Function Tests Rodents |
| title | Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: A double-blind, placebo-controlled, ascending-dose trial |
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