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SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation
Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was...
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| Published in: | Pulmonary circulation 2024-10, Vol.14 (4), p.e12446-n/a |
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| creator | Frantz, Robert P Desai, Shashank S Ewald, Gregory Franco, Veronica Hage, Antoine Horn, Evelyn M LaRue, Shane J Mathier, Michael A Mandras, Stacy Park, Myung H Ravichandran, Ashwin K Schilling, Joel D Wang, I-Wen Zolty, Ronald Rendon, Gabriela Gomez Rocco, Mark A Selej, Mona Zhao, Carol Rame, J Eduardo |
| description | Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (
= 28) or placebo (
= 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94;
= .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR |
| doi_str_mv | 10.1002/pul2.12446 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_f553630ff6f5479d8160083ddd02b769</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_f553630ff6f5479d8160083ddd02b769</doaj_id><sourcerecordid>3146520637</sourcerecordid><originalsourceid>FETCH-LOGICAL-c326t-c7245329fc8ec5c8ed7aadf507dcaff2e439d21e265b9a189bd14de7e823c9c53</originalsourceid><addsrcrecordid>eNpdUstuEzEUHSEQrUo3fACyxAYhpfg9YzaoqqCtVAjisbYcPxJHnvHU9qTq3-NpSkTxws9zj8-99zTNawTPEIT4wzgFfIYwpfxZc4whZYtOUPj8sCf4qDnNeQvroAJh2L1sjojghFHOjpvbn8vvP86_LT-Cr0r7YoeiBuAHMKri6yGDO182oH7Sx0Gle7C5H22qsOzjAFwMId75YQ2CdQXsakDyegoqAZWzzwUYu_PaAt-PQVXqUqNeNS-cCtmePq4nze8vn39dXC1ulpfXF-c3C00wLwvdYsoIFk53VrM6mVYp4xhsjVbOYUuJMBhZzNlKKNSJlUHU2NZ2mGihGTlprve8JqqtHJPvq34ZlZcPFzGtpUrF62ClY4xwAp3jjtFWmA5xCDtijIF41XJRuT7tucZp1Vuj50RVeEL69GXwG7mOO4kQR6xltDK8e2RI8XayucjeZ21DLYuNU5YE1XZgyElboW__g27jlIZaqxlVG0oJn9N7v0fpFHNO1h3UIChnZ8jZGfLBGRX85l_9B-hfH5A_7ei2UQ</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3149324365</pqid></control><display><type>article</type><title>SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation</title><source>Open Access: PubMed Central</source><source>Open Access: Wiley-Blackwell Open Access Journals</source><source>Publicly Available Content Database</source><creator>Frantz, Robert P ; Desai, Shashank S ; Ewald, Gregory ; Franco, Veronica ; Hage, Antoine ; Horn, Evelyn M ; LaRue, Shane J ; Mathier, Michael A ; Mandras, Stacy ; Park, Myung H ; Ravichandran, Ashwin K ; Schilling, Joel D ; Wang, I-Wen ; Zolty, Ronald ; Rendon, Gabriela Gomez ; Rocco, Mark A ; Selej, Mona ; Zhao, Carol ; Rame, J Eduardo</creator><creatorcontrib>Frantz, Robert P ; Desai, Shashank S ; Ewald, Gregory ; Franco, Veronica ; Hage, Antoine ; Horn, Evelyn M ; LaRue, Shane J ; Mathier, Michael A ; Mandras, Stacy ; Park, Myung H ; Ravichandran, Ashwin K ; Schilling, Joel D ; Wang, I-Wen ; Zolty, Ronald ; Rendon, Gabriela Gomez ; Rocco, Mark A ; Selej, Mona ; Zhao, Carol ; Rame, J Eduardo</creatorcontrib><description>Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (
= 28) or placebo (
= 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94;
= .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR <3 WU versus 40.0% receiving placebo (
= .0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903.</description><identifier>ISSN: 2045-8932</identifier><identifier>ISSN: 2045-8940</identifier><identifier>EISSN: 2045-8940</identifier><identifier>DOI: 10.1002/pul2.12446</identifier><identifier>PMID: 39635465</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>left ventricular assist device ; macitentan ; Pulmonary arteries ; Pulmonary hypertension ; pulmonary vascular resistance ; SOPRANO</subject><ispartof>Pulmonary circulation, 2024-10, Vol.14 (4), p.e12446-n/a</ispartof><rights>2024 Actelion Pharmaceuticals US, Inc. Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2024 Actelion Pharmaceuticals US, Inc. published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-c7245329fc8ec5c8ed7aadf507dcaff2e439d21e265b9a189bd14de7e823c9c53</cites><orcidid>0000-0003-4128-3978 ; 0000-0002-3884-1994</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615754/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11615754/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,36989,36990,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39635465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Frantz, Robert P</creatorcontrib><creatorcontrib>Desai, Shashank S</creatorcontrib><creatorcontrib>Ewald, Gregory</creatorcontrib><creatorcontrib>Franco, Veronica</creatorcontrib><creatorcontrib>Hage, Antoine</creatorcontrib><creatorcontrib>Horn, Evelyn M</creatorcontrib><creatorcontrib>LaRue, Shane J</creatorcontrib><creatorcontrib>Mathier, Michael A</creatorcontrib><creatorcontrib>Mandras, Stacy</creatorcontrib><creatorcontrib>Park, Myung H</creatorcontrib><creatorcontrib>Ravichandran, Ashwin K</creatorcontrib><creatorcontrib>Schilling, Joel D</creatorcontrib><creatorcontrib>Wang, I-Wen</creatorcontrib><creatorcontrib>Zolty, Ronald</creatorcontrib><creatorcontrib>Rendon, Gabriela Gomez</creatorcontrib><creatorcontrib>Rocco, Mark A</creatorcontrib><creatorcontrib>Selej, Mona</creatorcontrib><creatorcontrib>Zhao, Carol</creatorcontrib><creatorcontrib>Rame, J Eduardo</creatorcontrib><title>SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation</title><title>Pulmonary circulation</title><addtitle>Pulm Circ</addtitle><description>Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (
= 28) or placebo (
= 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94;
= .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR <3 WU versus 40.0% receiving placebo (
= .0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903.</description><subject>left ventricular assist device</subject><subject>macitentan</subject><subject>Pulmonary arteries</subject><subject>Pulmonary hypertension</subject><subject>pulmonary vascular resistance</subject><subject>SOPRANO</subject><issn>2045-8932</issn><issn>2045-8940</issn><issn>2045-8940</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNpdUstuEzEUHSEQrUo3fACyxAYhpfg9YzaoqqCtVAjisbYcPxJHnvHU9qTq3-NpSkTxws9zj8-99zTNawTPEIT4wzgFfIYwpfxZc4whZYtOUPj8sCf4qDnNeQvroAJh2L1sjojghFHOjpvbn8vvP86_LT-Cr0r7YoeiBuAHMKri6yGDO182oH7Sx0Gle7C5H22qsOzjAFwMId75YQ2CdQXsakDyegoqAZWzzwUYu_PaAt-PQVXqUqNeNS-cCtmePq4nze8vn39dXC1ulpfXF-c3C00wLwvdYsoIFk53VrM6mVYp4xhsjVbOYUuJMBhZzNlKKNSJlUHU2NZ2mGihGTlprve8JqqtHJPvq34ZlZcPFzGtpUrF62ClY4xwAp3jjtFWmA5xCDtijIF41XJRuT7tucZp1Vuj50RVeEL69GXwG7mOO4kQR6xltDK8e2RI8XayucjeZ21DLYuNU5YE1XZgyElboW__g27jlIZaqxlVG0oJn9N7v0fpFHNO1h3UIChnZ8jZGfLBGRX85l_9B-hfH5A_7ei2UQ</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Frantz, Robert P</creator><creator>Desai, Shashank S</creator><creator>Ewald, Gregory</creator><creator>Franco, Veronica</creator><creator>Hage, Antoine</creator><creator>Horn, Evelyn M</creator><creator>LaRue, Shane J</creator><creator>Mathier, Michael A</creator><creator>Mandras, Stacy</creator><creator>Park, Myung H</creator><creator>Ravichandran, Ashwin K</creator><creator>Schilling, Joel D</creator><creator>Wang, I-Wen</creator><creator>Zolty, Ronald</creator><creator>Rendon, Gabriela Gomez</creator><creator>Rocco, Mark A</creator><creator>Selej, Mona</creator><creator>Zhao, Carol</creator><creator>Rame, J Eduardo</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><general>Wiley</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0003-4128-3978</orcidid><orcidid>https://orcid.org/0000-0002-3884-1994</orcidid></search><sort><creationdate>20241001</creationdate><title>SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation</title><author>Frantz, Robert P ; Desai, Shashank S ; Ewald, Gregory ; Franco, Veronica ; Hage, Antoine ; Horn, Evelyn M ; LaRue, Shane J ; Mathier, Michael A ; Mandras, Stacy ; Park, Myung H ; Ravichandran, Ashwin K ; Schilling, Joel D ; Wang, I-Wen ; Zolty, Ronald ; Rendon, Gabriela Gomez ; Rocco, Mark A ; Selej, Mona ; Zhao, Carol ; Rame, J Eduardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-c7245329fc8ec5c8ed7aadf507dcaff2e439d21e265b9a189bd14de7e823c9c53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>left ventricular assist device</topic><topic>macitentan</topic><topic>Pulmonary arteries</topic><topic>Pulmonary hypertension</topic><topic>pulmonary vascular resistance</topic><topic>SOPRANO</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Frantz, Robert P</creatorcontrib><creatorcontrib>Desai, Shashank S</creatorcontrib><creatorcontrib>Ewald, Gregory</creatorcontrib><creatorcontrib>Franco, Veronica</creatorcontrib><creatorcontrib>Hage, Antoine</creatorcontrib><creatorcontrib>Horn, Evelyn M</creatorcontrib><creatorcontrib>LaRue, Shane J</creatorcontrib><creatorcontrib>Mathier, Michael A</creatorcontrib><creatorcontrib>Mandras, Stacy</creatorcontrib><creatorcontrib>Park, Myung H</creatorcontrib><creatorcontrib>Ravichandran, Ashwin K</creatorcontrib><creatorcontrib>Schilling, Joel D</creatorcontrib><creatorcontrib>Wang, I-Wen</creatorcontrib><creatorcontrib>Zolty, Ronald</creatorcontrib><creatorcontrib>Rendon, Gabriela Gomez</creatorcontrib><creatorcontrib>Rocco, Mark A</creatorcontrib><creatorcontrib>Selej, Mona</creatorcontrib><creatorcontrib>Zhao, Carol</creatorcontrib><creatorcontrib>Rame, J Eduardo</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Pulmonary circulation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Frantz, Robert P</au><au>Desai, Shashank S</au><au>Ewald, Gregory</au><au>Franco, Veronica</au><au>Hage, Antoine</au><au>Horn, Evelyn M</au><au>LaRue, Shane J</au><au>Mathier, Michael A</au><au>Mandras, Stacy</au><au>Park, Myung H</au><au>Ravichandran, Ashwin K</au><au>Schilling, Joel D</au><au>Wang, I-Wen</au><au>Zolty, Ronald</au><au>Rendon, Gabriela Gomez</au><au>Rocco, Mark A</au><au>Selej, Mona</au><au>Zhao, Carol</au><au>Rame, J Eduardo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation</atitle><jtitle>Pulmonary circulation</jtitle><addtitle>Pulm Circ</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>14</volume><issue>4</issue><spage>e12446</spage><epage>n/a</epage><pages>e12446-n/a</pages><issn>2045-8932</issn><issn>2045-8940</issn><eissn>2045-8940</eissn><abstract>Macitentan is a dual endothelin receptor antagonist (ERA) approved for treating pulmonary arterial hypertension (PAH). SOPRANO evaluated the efficacy and safety of macitentan versus placebo in pulmonary hypertension (PH) patients after left ventricular assist device (LVAD) implantation. SOPRANO was a phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group study. Patients with an LVAD implanted within the prior 90 days who had persistent PH (i.e., mean pulmonary arterial pressure ≥25 mmHg, pulmonary artery wedge pressure [PAWP] ≤18 mmHg, and pulmonary vascular resistance [PVR] >3 Wood units [WU]) were randomized (1:1) to macitentan 10 mg or placebo once daily for 12 weeks. The primary endpoint was change in PVR. Secondary endpoints included change in right-heart catheterization hemodynamic variables, N-terminal prohormone of brain natriuretic peptide levels, World Health Organization functional class, and safety/tolerability. Fifty-seven patients were randomized to macitentan (
= 28) or placebo (
= 29). A statistically significant reduction in PVR from baseline to Week 12 was observed with macitentan versus placebo (placebo-corrected geometric mean ratio, 0.74; 95% confidence interval, 0.58-0.94;
= .0158). No statistically significant differences were observed in secondary endpoints. In a post-hoc analysis, 66.7% of patients receiving macitentan achieved PVR <3 WU versus 40.0% receiving placebo (
= .0383). Macitentan was generally well tolerated; adverse events were consistent with those in previous PAH studies with macitentan. In conclusion, macitentan showed promising tolerability and significantly reduced PVR in PH patients with persistently elevated PVR after LVAD implantation. ClinicalTrials. gov identifier: NCT02554903.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>39635465</pmid><doi>10.1002/pul2.12446</doi><orcidid>https://orcid.org/0000-0003-4128-3978</orcidid><orcidid>https://orcid.org/0000-0002-3884-1994</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Open Access: PubMed Central; Open Access: Wiley-Blackwell Open Access Journals; Publicly Available Content Database |
| subjects | left ventricular assist device macitentan Pulmonary arteries Pulmonary hypertension pulmonary vascular resistance SOPRANO |
| title | SOPRANO: Macitentan in patients with pulmonary hypertension following left ventricular assist device implantation |
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