Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration
Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analy...
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| Veröffentlicht in: | The American heart journal 2015-05, Vol.169 (5), p.605-612 |
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| container_title | The American heart journal |
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| creator | Pitcher, Alex, BMBCh Emberson, Jonathan, PhD Lacro, Ronald V., MD Sleeper, Lynn A., Sc.D Stylianou, Mario, PhD Mahony, Lynn, MD Pearson, Gail D., MD, ScD Groenink, Maarten, MD, PhD Mulder, Barbara J., MD, PhD Zwinderman, Aeilko H., PhD De Backer, Julie, MD, PhD De Paepe, Anne M., MD, PhD Arbustini, Eloisa, MD Erdem, Guliz, MD Jin, Xu Yu, MD Flather, Marcus D., MBBS Mullen, Michael J., MD Child, Anne H., MD, FRCP Forteza, Alberto, MD, PhD Evangelista, Arturo, MD Chiu, Hsin-Hui, MD Wu, Mei-Hwan, MD, PhD Sandor, George, MD, FRCPC Bhatt, Ami B., MD Creager, Mark A., MD Devereux, Richard B., MD Loeys, Bart, MD, PhD Forfar, J. Colin, MD, PhD Neubauer, Stefan, MD Watkins, Hugh, MD, PhD Boileau, Catherine, PharmD, PhD Jondeau, Guillaume, MD, PhD Dietz, Harry C., MD Baigent, Colin, BM, BCh |
| description | Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online ( http://www.ctsu.ox.ac.uk/research/meta-trials ). |
| doi_str_mv | 10.1016/j.ahj.2015.01.011 |
| format | Article |
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Colin, MD, PhD ; Neubauer, Stefan, MD ; Watkins, Hugh, MD, PhD ; Boileau, Catherine, PharmD, PhD ; Jondeau, Guillaume, MD, PhD ; Dietz, Harry C., MD ; Baigent, Colin, BM, BCh</creator><creatorcontrib>Pitcher, Alex, BMBCh ; Emberson, Jonathan, PhD ; Lacro, Ronald V., MD ; Sleeper, Lynn A., Sc.D ; Stylianou, Mario, PhD ; Mahony, Lynn, MD ; Pearson, Gail D., MD, ScD ; Groenink, Maarten, MD, PhD ; Mulder, Barbara J., MD, PhD ; Zwinderman, Aeilko H., PhD ; De Backer, Julie, MD, PhD ; De Paepe, Anne M., MD, PhD ; Arbustini, Eloisa, MD ; Erdem, Guliz, MD ; Jin, Xu Yu, MD ; Flather, Marcus D., MBBS ; Mullen, Michael J., MD ; Child, Anne H., MD, FRCP ; Forteza, Alberto, MD, PhD ; Evangelista, Arturo, MD ; Chiu, Hsin-Hui, MD ; Wu, Mei-Hwan, MD, PhD ; Sandor, George, MD, FRCPC ; Bhatt, Ami B., MD ; Creager, Mark A., MD ; Devereux, Richard B., MD ; Loeys, Bart, MD, PhD ; Forfar, J. Colin, MD, PhD ; Neubauer, Stefan, MD ; Watkins, Hugh, MD, PhD ; Boileau, Catherine, PharmD, PhD ; Jondeau, Guillaume, MD, PhD ; Dietz, Harry C., MD ; Baigent, Colin, BM, BCh</creatorcontrib><description>Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online ( http://www.ctsu.ox.ac.uk/research/meta-trials ).</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2015.01.011</identifier><identifier>PMID: 25965707</identifier><identifier>CODEN: AHJOA2</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Age ; Angiotensin Receptor Antagonists - therapeutic use ; Biomarkers ; Cardiology ; Cardiovascular ; Clinical trials ; Dissection ; Extracellular matrix ; Female ; Humans ; Hypotheses ; Male ; Marfan syndrome ; Marfan Syndrome - drug therapy ; Meta-analysis ; Meta-Analysis as Topic ; Methods ; Mutation ; NMR ; Nuclear magnetic resonance ; Prospective Studies ; Pulmonary arteries ; Randomized Controlled Trials as Topic ; Research Design ; Sinuses ; Statistical analysis ; Studies ; Surgery ; Trial Design</subject><ispartof>The American heart journal, 2015-05, Vol.169 (5), p.605-612</ispartof><rights>The Authors</rights><rights>2015 The Authors</rights><rights>Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited May 2015</rights><rights>2015 The Authors 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c604t-eebeb551082b338d8eb369b6531841a102b50ab9402cf774991a7ac236a58c263</citedby><cites>FETCH-LOGICAL-c604t-eebeb551082b338d8eb369b6531841a102b50ab9402cf774991a7ac236a58c263</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0002870315001015$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25965707$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pitcher, Alex, BMBCh</creatorcontrib><creatorcontrib>Emberson, Jonathan, PhD</creatorcontrib><creatorcontrib>Lacro, Ronald V., MD</creatorcontrib><creatorcontrib>Sleeper, Lynn A., Sc.D</creatorcontrib><creatorcontrib>Stylianou, Mario, PhD</creatorcontrib><creatorcontrib>Mahony, Lynn, MD</creatorcontrib><creatorcontrib>Pearson, Gail D., MD, ScD</creatorcontrib><creatorcontrib>Groenink, Maarten, MD, PhD</creatorcontrib><creatorcontrib>Mulder, Barbara J., MD, PhD</creatorcontrib><creatorcontrib>Zwinderman, Aeilko H., PhD</creatorcontrib><creatorcontrib>De Backer, Julie, MD, PhD</creatorcontrib><creatorcontrib>De Paepe, Anne M., MD, PhD</creatorcontrib><creatorcontrib>Arbustini, Eloisa, MD</creatorcontrib><creatorcontrib>Erdem, Guliz, MD</creatorcontrib><creatorcontrib>Jin, Xu Yu, MD</creatorcontrib><creatorcontrib>Flather, Marcus D., MBBS</creatorcontrib><creatorcontrib>Mullen, Michael J., MD</creatorcontrib><creatorcontrib>Child, Anne H., MD, FRCP</creatorcontrib><creatorcontrib>Forteza, Alberto, MD, PhD</creatorcontrib><creatorcontrib>Evangelista, Arturo, MD</creatorcontrib><creatorcontrib>Chiu, Hsin-Hui, MD</creatorcontrib><creatorcontrib>Wu, Mei-Hwan, MD, PhD</creatorcontrib><creatorcontrib>Sandor, George, MD, FRCPC</creatorcontrib><creatorcontrib>Bhatt, Ami B., MD</creatorcontrib><creatorcontrib>Creager, Mark A., MD</creatorcontrib><creatorcontrib>Devereux, Richard B., MD</creatorcontrib><creatorcontrib>Loeys, Bart, MD, PhD</creatorcontrib><creatorcontrib>Forfar, J. Colin, MD, PhD</creatorcontrib><creatorcontrib>Neubauer, Stefan, MD</creatorcontrib><creatorcontrib>Watkins, Hugh, MD, PhD</creatorcontrib><creatorcontrib>Boileau, Catherine, PharmD, PhD</creatorcontrib><creatorcontrib>Jondeau, Guillaume, MD, PhD</creatorcontrib><creatorcontrib>Dietz, Harry C., MD</creatorcontrib><creatorcontrib>Baigent, Colin, BM, BCh</creatorcontrib><title>Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online ( http://www.ctsu.ox.ac.uk/research/meta-trials ).</description><subject>Age</subject><subject>Angiotensin Receptor Antagonists - therapeutic use</subject><subject>Biomarkers</subject><subject>Cardiology</subject><subject>Cardiovascular</subject><subject>Clinical trials</subject><subject>Dissection</subject><subject>Extracellular matrix</subject><subject>Female</subject><subject>Humans</subject><subject>Hypotheses</subject><subject>Male</subject><subject>Marfan syndrome</subject><subject>Marfan Syndrome - drug therapy</subject><subject>Meta-analysis</subject><subject>Meta-Analysis as Topic</subject><subject>Methods</subject><subject>Mutation</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Prospective Studies</subject><subject>Pulmonary arteries</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research Design</subject><subject>Sinuses</subject><subject>Statistical analysis</subject><subject>Studies</subject><subject>Surgery</subject><subject>Trial Design</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kkuP0zAUhSMEYsrAD2CDLLGABSl2EucB0kij8pQGsaCsrRvntnVJ7GC7lcpvZ8HNdB4wCyRLSezvHN-be5LkqeBzwUX5ejuHzXaecSHnXNAS95KZ4E2VllVR3E9mnPMsrSuenySPQtjSZ5nV5cPkJJNNKStezZLf7zCYtWVgO-YhGmehR-ZWDNjoXRhRR7PHV0y7vofWTcge2YARUiD0EEy4pPue5LZzg_mFHdE2elLQa_QG-iNj18ZFtMFY5lHjGJ2nzQhrZ02IgdH-F_ArsCwcbOfdQPe2EMjEWTrszN50O-jZSEWgjayDCG_YOZmNzke2IgWLG7w2WXqEOEzgcqphuuIFW9z24ezj5MGKisMnV8_T5PuH98vFp_Ti68fPi_OLVJe8iClii62UgtdZm-d1V2Obl01bylzUhQDBs1ZyaJuCZ3pVVUXTCKhAZ3kJstZZmZ8mZ0ffcdcO2GmqyUOvRm8G8AflwKh_T6zZqLXbq6IohOAFGby8MvDu5w5DVIMJGqkVi24XlChr3sgmKyShz--gW7fzNKpLSjRVwUtOlDhSmoYcPK5uihFcTdlSW0XZUlO2FBe0BGme_d3FjeI6TAS8PQJI_3Jv0KugaVAaO0Pzjqpz5r_2Z3fUujfWaOh_4AHDbRcqZIqrb1O4p2wLyTlZyvwPIEb6_g</recordid><startdate>20150501</startdate><enddate>20150501</enddate><creator>Pitcher, Alex, BMBCh</creator><creator>Emberson, Jonathan, PhD</creator><creator>Lacro, Ronald V., MD</creator><creator>Sleeper, Lynn A., Sc.D</creator><creator>Stylianou, Mario, PhD</creator><creator>Mahony, Lynn, MD</creator><creator>Pearson, Gail D., MD, ScD</creator><creator>Groenink, Maarten, MD, PhD</creator><creator>Mulder, Barbara J., MD, PhD</creator><creator>Zwinderman, Aeilko H., PhD</creator><creator>De Backer, Julie, MD, PhD</creator><creator>De Paepe, Anne M., MD, PhD</creator><creator>Arbustini, Eloisa, MD</creator><creator>Erdem, Guliz, MD</creator><creator>Jin, Xu Yu, MD</creator><creator>Flather, Marcus D., MBBS</creator><creator>Mullen, Michael J., MD</creator><creator>Child, Anne H., MD, FRCP</creator><creator>Forteza, Alberto, MD, PhD</creator><creator>Evangelista, Arturo, MD</creator><creator>Chiu, Hsin-Hui, MD</creator><creator>Wu, Mei-Hwan, MD, PhD</creator><creator>Sandor, George, MD, FRCPC</creator><creator>Bhatt, Ami B., MD</creator><creator>Creager, Mark A., MD</creator><creator>Devereux, Richard B., MD</creator><creator>Loeys, Bart, MD, PhD</creator><creator>Forfar, J. 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Colin, MD, PhD ; Neubauer, Stefan, MD ; Watkins, Hugh, MD, PhD ; Boileau, Catherine, PharmD, PhD ; Jondeau, Guillaume, MD, PhD ; Dietz, Harry C., MD ; Baigent, Colin, BM, BCh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c604t-eebeb551082b338d8eb369b6531841a102b50ab9402cf774991a7ac236a58c263</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Age</topic><topic>Angiotensin Receptor Antagonists - therapeutic use</topic><topic>Biomarkers</topic><topic>Cardiology</topic><topic>Cardiovascular</topic><topic>Clinical trials</topic><topic>Dissection</topic><topic>Extracellular matrix</topic><topic>Female</topic><topic>Humans</topic><topic>Hypotheses</topic><topic>Male</topic><topic>Marfan syndrome</topic><topic>Marfan Syndrome - drug therapy</topic><topic>Meta-analysis</topic><topic>Meta-Analysis as Topic</topic><topic>Methods</topic><topic>Mutation</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Prospective Studies</topic><topic>Pulmonary arteries</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Research Design</topic><topic>Sinuses</topic><topic>Statistical analysis</topic><topic>Studies</topic><topic>Surgery</topic><topic>Trial Design</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pitcher, Alex, BMBCh</creatorcontrib><creatorcontrib>Emberson, Jonathan, PhD</creatorcontrib><creatorcontrib>Lacro, Ronald V., MD</creatorcontrib><creatorcontrib>Sleeper, Lynn A., Sc.D</creatorcontrib><creatorcontrib>Stylianou, Mario, PhD</creatorcontrib><creatorcontrib>Mahony, Lynn, MD</creatorcontrib><creatorcontrib>Pearson, Gail D., MD, ScD</creatorcontrib><creatorcontrib>Groenink, Maarten, MD, PhD</creatorcontrib><creatorcontrib>Mulder, Barbara J., MD, PhD</creatorcontrib><creatorcontrib>Zwinderman, Aeilko H., PhD</creatorcontrib><creatorcontrib>De Backer, Julie, MD, PhD</creatorcontrib><creatorcontrib>De Paepe, Anne M., MD, PhD</creatorcontrib><creatorcontrib>Arbustini, Eloisa, MD</creatorcontrib><creatorcontrib>Erdem, Guliz, MD</creatorcontrib><creatorcontrib>Jin, Xu Yu, MD</creatorcontrib><creatorcontrib>Flather, Marcus D., MBBS</creatorcontrib><creatorcontrib>Mullen, Michael J., MD</creatorcontrib><creatorcontrib>Child, Anne H., MD, FRCP</creatorcontrib><creatorcontrib>Forteza, Alberto, MD, PhD</creatorcontrib><creatorcontrib>Evangelista, Arturo, MD</creatorcontrib><creatorcontrib>Chiu, Hsin-Hui, MD</creatorcontrib><creatorcontrib>Wu, Mei-Hwan, MD, PhD</creatorcontrib><creatorcontrib>Sandor, George, MD, FRCPC</creatorcontrib><creatorcontrib>Bhatt, Ami B., MD</creatorcontrib><creatorcontrib>Creager, Mark A., MD</creatorcontrib><creatorcontrib>Devereux, Richard B., MD</creatorcontrib><creatorcontrib>Loeys, Bart, MD, PhD</creatorcontrib><creatorcontrib>Forfar, J. Colin, MD, PhD</creatorcontrib><creatorcontrib>Neubauer, Stefan, MD</creatorcontrib><creatorcontrib>Watkins, Hugh, MD, PhD</creatorcontrib><creatorcontrib>Boileau, Catherine, PharmD, PhD</creatorcontrib><creatorcontrib>Jondeau, Guillaume, MD, PhD</creatorcontrib><creatorcontrib>Dietz, Harry C., MD</creatorcontrib><creatorcontrib>Baigent, Colin, BM, BCh</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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 Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pitcher, Alex, BMBCh</au><au>Emberson, Jonathan, PhD</au><au>Lacro, Ronald V., MD</au><au>Sleeper, Lynn A., Sc.D</au><au>Stylianou, Mario, PhD</au><au>Mahony, Lynn, MD</au><au>Pearson, Gail D., MD, ScD</au><au>Groenink, Maarten, MD, PhD</au><au>Mulder, Barbara J., MD, PhD</au><au>Zwinderman, Aeilko H., PhD</au><au>De Backer, Julie, MD, PhD</au><au>De Paepe, Anne M., MD, PhD</au><au>Arbustini, Eloisa, MD</au><au>Erdem, Guliz, MD</au><au>Jin, Xu Yu, MD</au><au>Flather, Marcus D., MBBS</au><au>Mullen, Michael J., MD</au><au>Child, Anne H., MD, FRCP</au><au>Forteza, Alberto, MD, PhD</au><au>Evangelista, Arturo, MD</au><au>Chiu, Hsin-Hui, MD</au><au>Wu, Mei-Hwan, MD, PhD</au><au>Sandor, George, MD, FRCPC</au><au>Bhatt, Ami B., MD</au><au>Creager, Mark A., MD</au><au>Devereux, Richard B., MD</au><au>Loeys, Bart, MD, PhD</au><au>Forfar, J. Colin, MD, PhD</au><au>Neubauer, Stefan, MD</au><au>Watkins, Hugh, MD, PhD</au><au>Boileau, Catherine, PharmD, PhD</au><au>Jondeau, Guillaume, MD, PhD</au><au>Dietz, Harry C., MD</au><au>Baigent, Colin, BM, BCh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2015-05-01</date><risdate>2015</risdate><volume>169</volume><issue>5</issue><spage>605</spage><epage>612</epage><pages>605-612</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><coden>AHJOA2</coden><abstract>Rationale A number of randomized trials are underway, which will address the effects of angiotensin receptor blockers (ARBs) on aortic root enlargement and a range of other end points in patients with Marfan syndrome. If individual participant data from these trials were to be combined, a meta-analysis of the resulting data, totaling approximately 2,300 patients, would allow estimation across a number of trials of the treatment effects both of ARB therapy and of β-blockade. Such an analysis would also allow estimation of treatment effects in particular subgroups of patients on a range of end points of interest and would allow a more powerful estimate of the effects of these treatments on a composite end point of several clinical outcomes than would be available from any individual trial. Design A prospective, collaborative meta-analysis based on individual patient data from all randomized trials in Marfan syndrome of (i) ARBs versus placebo (or open-label control) and (ii) ARBs versus β-blockers will be performed. A prospective study design, in which the principal hypotheses, trial eligibility criteria, analyses, and methods are specified in advance of the unblinding of the component trials, will help to limit bias owing to data-dependent emphasis on the results of particular trials. The use of individual patient data will allow for analysis of the effects of ARBs in particular patient subgroups and for time-to-event analysis for clinical outcomes. The meta-analysis protocol summarized in this report was written on behalf of the Marfan Treatment Trialists' Collaboration and finalized in late 2012, without foreknowledge of the results of any component trial, and will be made available online ( http://www.ctsu.ox.ac.uk/research/meta-trials ).</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>25965707</pmid><doi>10.1016/j.ahj.2015.01.011</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2015-05, Vol.169 (5), p.605-612 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4441104 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Age Angiotensin Receptor Antagonists - therapeutic use Biomarkers Cardiology Cardiovascular Clinical trials Dissection Extracellular matrix Female Humans Hypotheses Male Marfan syndrome Marfan Syndrome - drug therapy Meta-analysis Meta-Analysis as Topic Methods Mutation NMR Nuclear magnetic resonance Prospective Studies Pulmonary arteries Randomized Controlled Trials as Topic Research Design Sinuses Statistical analysis Studies Surgery Trial Design |
| title | Design and rationale of a prospective, collaborative meta-analysis of all randomized controlled trials of angiotensin receptor antagonists in Marfan syndrome, based on individual patient data: A report from the Marfan Treatment Trialists' Collaboration |
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