Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel
The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of H...
Gespeichert in:
| Veröffentlicht in: | JACC. Heart failure 2022-12, Vol.10 (12), p.889-901 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 901 |
|---|---|
| container_issue | 12 |
| container_start_page | 889 |
| container_title | JACC. Heart failure |
| container_volume | 10 |
| creator | Psotka, Mitchell A Abraham, William T Fiuzat, Mona Filippatos, Gerasimos Lindenfeld, JoAnn Ahmad, Tariq Felker, G Michael Jacob, Richard Kitzman, Dalane W Leifer, Eric S Lewis, Eldrin F Mentz, Robert J Nkulikiyinka, Richard Ni, Wei Schaber, Daniel E Sharma, Abhinav Solomon, Scott D Stockbridge, Norman Teerlink, John R Unger, Ellis F Whellan, David J Wittes, Janet Anker, Stefan D O'Connor, Christopher M |
| description | The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations. |
| doi_str_mv | 10.1016/j.jchf.2022.09.012 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_2746390122</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2746390122</sourcerecordid><originalsourceid>FETCH-LOGICAL-c260t-9376618bcc623db9288f47843520c01ba97f774d12c2fe6d0845f752c44258203</originalsourceid><addsrcrecordid>eNo1kEFLwzAcxYMgbsx9AQ_So5fW5J80Sb2NsjlhoLh68VLSNGUZbVrbFNy38bP4yaw43-Vdfu_xeAjdEBwRTPj9MTrqQxUBBohwEmECF2gOQGhIhBQztByGI54kYyKlvEIzylnMMadz9L4Znfa2daoOlCuD_anpfNsob3WQ1tZZrervr6y3v7Z2Zdda54eHIDuYYLtJw9VrGuy1Nc7baoqsPzvT--BFOVNfo8tK1YNZnn2B3jbrLN2Gu-fHp3S1CzVw7MOECs6JLLTmQMsiASkrJiSjMWCNSaESUQnBSgIaKsNLLFlciRg0YxBLwHSB7v56u779GM3g88YO2tT1NKIdhxwE4zSZToEJvT2jY9GYMu9626j-lP__QX8AJ8NhdA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2746390122</pqid></control><display><type>article</type><title>Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel</title><source>MEDLINE</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Alma/SFX Local Collection</source><creator>Psotka, Mitchell A ; Abraham, William T ; Fiuzat, Mona ; Filippatos, Gerasimos ; Lindenfeld, JoAnn ; Ahmad, Tariq ; Felker, G Michael ; Jacob, Richard ; Kitzman, Dalane W ; Leifer, Eric S ; Lewis, Eldrin F ; Mentz, Robert J ; Nkulikiyinka, Richard ; Ni, Wei ; Schaber, Daniel E ; Sharma, Abhinav ; Solomon, Scott D ; Stockbridge, Norman ; Teerlink, John R ; Unger, Ellis F ; Whellan, David J ; Wittes, Janet ; Anker, Stefan D ; O'Connor, Christopher M</creator><creatorcontrib>Psotka, Mitchell A ; Abraham, William T ; Fiuzat, Mona ; Filippatos, Gerasimos ; Lindenfeld, JoAnn ; Ahmad, Tariq ; Felker, G Michael ; Jacob, Richard ; Kitzman, Dalane W ; Leifer, Eric S ; Lewis, Eldrin F ; Mentz, Robert J ; Nkulikiyinka, Richard ; Ni, Wei ; Schaber, Daniel E ; Sharma, Abhinav ; Solomon, Scott D ; Stockbridge, Norman ; Teerlink, John R ; Unger, Ellis F ; Whellan, David J ; Wittes, Janet ; Anker, Stefan D ; O'Connor, Christopher M</creatorcontrib><description>The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations.</description><identifier>EISSN: 2213-1787</identifier><identifier>DOI: 10.1016/j.jchf.2022.09.012</identifier><identifier>PMID: 36456063</identifier><language>eng</language><publisher>United States</publisher><subject>Exercise Tolerance ; Heart Failure - therapy ; Humans ; National Institutes of Health (U.S.) ; Quality of Life ; Research Personnel ; United States</subject><ispartof>JACC. Heart failure, 2022-12, Vol.10 (12), p.889-901</ispartof><rights>Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c260t-9376618bcc623db9288f47843520c01ba97f774d12c2fe6d0845f752c44258203</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36456063$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Psotka, Mitchell A</creatorcontrib><creatorcontrib>Abraham, William T</creatorcontrib><creatorcontrib>Fiuzat, Mona</creatorcontrib><creatorcontrib>Filippatos, Gerasimos</creatorcontrib><creatorcontrib>Lindenfeld, JoAnn</creatorcontrib><creatorcontrib>Ahmad, Tariq</creatorcontrib><creatorcontrib>Felker, G Michael</creatorcontrib><creatorcontrib>Jacob, Richard</creatorcontrib><creatorcontrib>Kitzman, Dalane W</creatorcontrib><creatorcontrib>Leifer, Eric S</creatorcontrib><creatorcontrib>Lewis, Eldrin F</creatorcontrib><creatorcontrib>Mentz, Robert J</creatorcontrib><creatorcontrib>Nkulikiyinka, Richard</creatorcontrib><creatorcontrib>Ni, Wei</creatorcontrib><creatorcontrib>Schaber, Daniel E</creatorcontrib><creatorcontrib>Sharma, Abhinav</creatorcontrib><creatorcontrib>Solomon, Scott D</creatorcontrib><creatorcontrib>Stockbridge, Norman</creatorcontrib><creatorcontrib>Teerlink, John R</creatorcontrib><creatorcontrib>Unger, Ellis F</creatorcontrib><creatorcontrib>Whellan, David J</creatorcontrib><creatorcontrib>Wittes, Janet</creatorcontrib><creatorcontrib>Anker, Stefan D</creatorcontrib><creatorcontrib>O'Connor, Christopher M</creatorcontrib><title>Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel</title><title>JACC. Heart failure</title><addtitle>JACC Heart Fail</addtitle><description>The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations.</description><subject>Exercise Tolerance</subject><subject>Heart Failure - therapy</subject><subject>Humans</subject><subject>National Institutes of Health (U.S.)</subject><subject>Quality of Life</subject><subject>Research Personnel</subject><subject>United States</subject><issn>2213-1787</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo1kEFLwzAcxYMgbsx9AQ_So5fW5J80Sb2NsjlhoLh68VLSNGUZbVrbFNy38bP4yaw43-Vdfu_xeAjdEBwRTPj9MTrqQxUBBohwEmECF2gOQGhIhBQztByGI54kYyKlvEIzylnMMadz9L4Znfa2daoOlCuD_anpfNsob3WQ1tZZrervr6y3v7Z2Zdda54eHIDuYYLtJw9VrGuy1Nc7baoqsPzvT--BFOVNfo8tK1YNZnn2B3jbrLN2Gu-fHp3S1CzVw7MOECs6JLLTmQMsiASkrJiSjMWCNSaESUQnBSgIaKsNLLFlciRg0YxBLwHSB7v56u779GM3g88YO2tT1NKIdhxwE4zSZToEJvT2jY9GYMu9626j-lP__QX8AJ8NhdA</recordid><startdate>202212</startdate><enddate>202212</enddate><creator>Psotka, Mitchell A</creator><creator>Abraham, William T</creator><creator>Fiuzat, Mona</creator><creator>Filippatos, Gerasimos</creator><creator>Lindenfeld, JoAnn</creator><creator>Ahmad, Tariq</creator><creator>Felker, G Michael</creator><creator>Jacob, Richard</creator><creator>Kitzman, Dalane W</creator><creator>Leifer, Eric S</creator><creator>Lewis, Eldrin F</creator><creator>Mentz, Robert J</creator><creator>Nkulikiyinka, Richard</creator><creator>Ni, Wei</creator><creator>Schaber, Daniel E</creator><creator>Sharma, Abhinav</creator><creator>Solomon, Scott D</creator><creator>Stockbridge, Norman</creator><creator>Teerlink, John R</creator><creator>Unger, Ellis F</creator><creator>Whellan, David J</creator><creator>Wittes, Janet</creator><creator>Anker, Stefan D</creator><creator>O'Connor, Christopher M</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>202212</creationdate><title>Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel</title><author>Psotka, Mitchell A ; Abraham, William T ; Fiuzat, Mona ; Filippatos, Gerasimos ; Lindenfeld, JoAnn ; Ahmad, Tariq ; Felker, G Michael ; Jacob, Richard ; Kitzman, Dalane W ; Leifer, Eric S ; Lewis, Eldrin F ; Mentz, Robert J ; Nkulikiyinka, Richard ; Ni, Wei ; Schaber, Daniel E ; Sharma, Abhinav ; Solomon, Scott D ; Stockbridge, Norman ; Teerlink, John R ; Unger, Ellis F ; Whellan, David J ; Wittes, Janet ; Anker, Stefan D ; O'Connor, Christopher M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c260t-9376618bcc623db9288f47843520c01ba97f774d12c2fe6d0845f752c44258203</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Exercise Tolerance</topic><topic>Heart Failure - therapy</topic><topic>Humans</topic><topic>National Institutes of Health (U.S.)</topic><topic>Quality of Life</topic><topic>Research Personnel</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Psotka, Mitchell A</creatorcontrib><creatorcontrib>Abraham, William T</creatorcontrib><creatorcontrib>Fiuzat, Mona</creatorcontrib><creatorcontrib>Filippatos, Gerasimos</creatorcontrib><creatorcontrib>Lindenfeld, JoAnn</creatorcontrib><creatorcontrib>Ahmad, Tariq</creatorcontrib><creatorcontrib>Felker, G Michael</creatorcontrib><creatorcontrib>Jacob, Richard</creatorcontrib><creatorcontrib>Kitzman, Dalane W</creatorcontrib><creatorcontrib>Leifer, Eric S</creatorcontrib><creatorcontrib>Lewis, Eldrin F</creatorcontrib><creatorcontrib>Mentz, Robert J</creatorcontrib><creatorcontrib>Nkulikiyinka, Richard</creatorcontrib><creatorcontrib>Ni, Wei</creatorcontrib><creatorcontrib>Schaber, Daniel E</creatorcontrib><creatorcontrib>Sharma, Abhinav</creatorcontrib><creatorcontrib>Solomon, Scott D</creatorcontrib><creatorcontrib>Stockbridge, Norman</creatorcontrib><creatorcontrib>Teerlink, John R</creatorcontrib><creatorcontrib>Unger, Ellis F</creatorcontrib><creatorcontrib>Whellan, David J</creatorcontrib><creatorcontrib>Wittes, Janet</creatorcontrib><creatorcontrib>Anker, Stefan D</creatorcontrib><creatorcontrib>O'Connor, Christopher M</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Heart failure</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Psotka, Mitchell A</au><au>Abraham, William T</au><au>Fiuzat, Mona</au><au>Filippatos, Gerasimos</au><au>Lindenfeld, JoAnn</au><au>Ahmad, Tariq</au><au>Felker, G Michael</au><au>Jacob, Richard</au><au>Kitzman, Dalane W</au><au>Leifer, Eric S</au><au>Lewis, Eldrin F</au><au>Mentz, Robert J</au><au>Nkulikiyinka, Richard</au><au>Ni, Wei</au><au>Schaber, Daniel E</au><au>Sharma, Abhinav</au><au>Solomon, Scott D</au><au>Stockbridge, Norman</au><au>Teerlink, John R</au><au>Unger, Ellis F</au><au>Whellan, David J</au><au>Wittes, Janet</au><au>Anker, Stefan D</au><au>O'Connor, Christopher M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel</atitle><jtitle>JACC. Heart failure</jtitle><addtitle>JACC Heart Fail</addtitle><date>2022-12</date><risdate>2022</risdate><volume>10</volume><issue>12</issue><spage>889</spage><epage>901</epage><pages>889-901</pages><eissn>2213-1787</eissn><abstract>The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry. Members discussed the measure, remote capture, and clinical utility of functional and quality-of-life endpoints for use in clinical trials of heart failure and cardiovascular therapeutics, with the goal of improving the efficiency of heart failure and cardiovascular clinical research, evidence generation, and thereby patient quality of life, functional status, and survival. Assessments of patient-reported outcomes and maximal and submaximal exercise tolerance are standardized and validated, but actigraphy remains inconsistent as a potential endpoint. This paper details those discussions and consensus recommendations.</abstract><cop>United States</cop><pmid>36456063</pmid><doi>10.1016/j.jchf.2022.09.012</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | EISSN: 2213-1787 |
| ispartof | JACC. Heart failure, 2022-12, Vol.10 (12), p.889-901 |
| issn | 2213-1787 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2746390122 |
| source | MEDLINE; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Exercise Tolerance Heart Failure - therapy Humans National Institutes of Health (U.S.) Quality of Life Research Personnel United States |
| title | Functional and Symptomatic Clinical Trial Endpoints: The HFC-ARC Scientific Expert Panel |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T10%3A47%3A30IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Functional%20and%20Symptomatic%20Clinical%C2%A0Trial%C2%A0Endpoints:%20The%20HFC-ARC%20Scientific%20Expert%20Panel&rft.jtitle=JACC.%20Heart%20failure&rft.au=Psotka,%20Mitchell%20A&rft.date=2022-12&rft.volume=10&rft.issue=12&rft.spage=889&rft.epage=901&rft.pages=889-901&rft.eissn=2213-1787&rft_id=info:doi/10.1016/j.jchf.2022.09.012&rft_dat=%3Cproquest_pubme%3E2746390122%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2746390122&rft_id=info:pmid/36456063&rfr_iscdi=true |