The frailty syndrome and outcomes in the TOPCAT trial
Aims The impact of frailty on outcomes in randomized heart failure with preserved ejection fraction (HFpEF) trials has not been previously reported. This analysis sought to characterize frailty in a large contemporary HFpEF clinical trial cohort and to evaluate its impact on patient relevant outcome...
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| Veröffentlicht in: | European journal of heart failure 2018-11, Vol.20 (11), p.1570-1577 |
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| container_title | European journal of heart failure |
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| creator | Sanders, Natalie A. Supiano, Mark A. Lewis, Eldrin F. Liu, Jiankang Claggett, Brian Pfeffer, Marc A. Desai, Akshay S. Sweitzer, Nancy K. Solomon, Scott D. Fang, James C. |
| description | Aims
The impact of frailty on outcomes in randomized heart failure with preserved ejection fraction (HFpEF) trials has not been previously reported. This analysis sought to characterize frailty in a large contemporary HFpEF clinical trial cohort and to evaluate its impact on patient relevant outcomes.
Methods and results
Using data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, a frailty index (FI) was constructed at baseline using 39 clinical, laboratory, and self‐reported variables. The relationship between frailty and outcomes and the role of frailty in modulating the benefits of spironolactone were examined in a subset of 1767 TOPCAT patients. For the cohort as a whole (mean age 71.5 years, 49% female), the mean FI at baseline was 0.37 ± 0.11. Four frailty classes were defined ranging from FI 0.21). Mean age was lowest for the most frail class (69 ± 9 years for Class 4; 73 ± 10 years for Class 1; P |
| doi_str_mv | 10.1002/ejhf.1308 |
| format | Article |
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The impact of frailty on outcomes in randomized heart failure with preserved ejection fraction (HFpEF) trials has not been previously reported. This analysis sought to characterize frailty in a large contemporary HFpEF clinical trial cohort and to evaluate its impact on patient relevant outcomes.
Methods and results
Using data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, a frailty index (FI) was constructed at baseline using 39 clinical, laboratory, and self‐reported variables. The relationship between frailty and outcomes and the role of frailty in modulating the benefits of spironolactone were examined in a subset of 1767 TOPCAT patients. For the cohort as a whole (mean age 71.5 years, 49% female), the mean FI at baseline was 0.37 ± 0.11. Four frailty classes were defined ranging from FI < 0.3 to FI ≥ 0.5. Overall, 94% of subjects were considered frail (defined as a FI > 0.21). Mean age was lowest for the most frail class (69 ± 9 years for Class 4; 73 ± 10 years for Class 1; P < 0.001). Body mass index, systolic blood pressure, and pulse pressure all increased as FI increased. Both primary and secondary outcomes increased as frailty severity increased. There was no interaction between frailty class and treatment effect of spironolactone.
Conclusions
Frailty was very common in TOPCAT HFpEF participants. Greater frailty was associated with a higher risk of cardiovascular outcomes and mortality. The benefit of spironolactone on outcomes in TOPCAT was not attenuated by frailty class.</description><identifier>ISSN: 1388-9842</identifier><identifier>EISSN: 1879-0844</identifier><identifier>DOI: 10.1002/ejhf.1308</identifier><identifier>PMID: 30225878</identifier><language>eng</language><publisher>Oxford, UK: John Wiley & Sons, Ltd</publisher><subject>Aged ; Americas - epidemiology ; Double-Blind Method ; Female ; Frail Elderly ; Frailty ; Frailty - complications ; Frailty - mortality ; Frailty - physiopathology ; Georgia (Republic) - epidemiology ; Heart Failure - complications ; Heart Failure - drug therapy ; Heart Failure - physiopathology ; Heart failure with preserved ejection fraction ; Humans ; Male ; Mineralocorticoid Receptor Antagonists - therapeutic use ; Outcomes ; Russia - epidemiology ; Spironolactone - therapeutic use ; Stroke Volume - physiology ; Survival Rate - trends ; Treatment Outcome</subject><ispartof>European journal of heart failure, 2018-11, Vol.20 (11), p.1570-1577</ispartof><rights>2018 The Authors. © 2018 European Society of Cardiology</rights><rights>2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4268-93366e00b79927679e3bc8de82ece43041a40fc2467599872aeb7956601335963</citedby><cites>FETCH-LOGICAL-c4268-93366e00b79927679e3bc8de82ece43041a40fc2467599872aeb7956601335963</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fejhf.1308$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fejhf.1308$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30225878$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Sanders, Natalie A.</creatorcontrib><creatorcontrib>Supiano, Mark A.</creatorcontrib><creatorcontrib>Lewis, Eldrin F.</creatorcontrib><creatorcontrib>Liu, Jiankang</creatorcontrib><creatorcontrib>Claggett, Brian</creatorcontrib><creatorcontrib>Pfeffer, Marc A.</creatorcontrib><creatorcontrib>Desai, Akshay S.</creatorcontrib><creatorcontrib>Sweitzer, Nancy K.</creatorcontrib><creatorcontrib>Solomon, Scott D.</creatorcontrib><creatorcontrib>Fang, James C.</creatorcontrib><title>The frailty syndrome and outcomes in the TOPCAT trial</title><title>European journal of heart failure</title><addtitle>Eur J Heart Fail</addtitle><description>Aims
The impact of frailty on outcomes in randomized heart failure with preserved ejection fraction (HFpEF) trials has not been previously reported. This analysis sought to characterize frailty in a large contemporary HFpEF clinical trial cohort and to evaluate its impact on patient relevant outcomes.
Methods and results
Using data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, a frailty index (FI) was constructed at baseline using 39 clinical, laboratory, and self‐reported variables. The relationship between frailty and outcomes and the role of frailty in modulating the benefits of spironolactone were examined in a subset of 1767 TOPCAT patients. For the cohort as a whole (mean age 71.5 years, 49% female), the mean FI at baseline was 0.37 ± 0.11. Four frailty classes were defined ranging from FI < 0.3 to FI ≥ 0.5. Overall, 94% of subjects were considered frail (defined as a FI > 0.21). Mean age was lowest for the most frail class (69 ± 9 years for Class 4; 73 ± 10 years for Class 1; P < 0.001). Body mass index, systolic blood pressure, and pulse pressure all increased as FI increased. Both primary and secondary outcomes increased as frailty severity increased. There was no interaction between frailty class and treatment effect of spironolactone.
Conclusions
Frailty was very common in TOPCAT HFpEF participants. Greater frailty was associated with a higher risk of cardiovascular outcomes and mortality. The benefit of spironolactone on outcomes in TOPCAT was not attenuated by frailty class.</description><subject>Aged</subject><subject>Americas - epidemiology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Frail Elderly</subject><subject>Frailty</subject><subject>Frailty - complications</subject><subject>Frailty - mortality</subject><subject>Frailty - physiopathology</subject><subject>Georgia (Republic) - epidemiology</subject><subject>Heart Failure - complications</subject><subject>Heart Failure - drug therapy</subject><subject>Heart Failure - physiopathology</subject><subject>Heart failure with preserved ejection fraction</subject><subject>Humans</subject><subject>Male</subject><subject>Mineralocorticoid Receptor Antagonists - therapeutic use</subject><subject>Outcomes</subject><subject>Russia - epidemiology</subject><subject>Spironolactone - therapeutic use</subject><subject>Stroke Volume - physiology</subject><subject>Survival Rate - trends</subject><subject>Treatment Outcome</subject><issn>1388-9842</issn><issn>1879-0844</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10EtPwkAUBeCJ0YiiC_-A6VIXhXl1HktCQDQkuKjrydDehpI-cKaN6b93EHTn6t7Fl3OSg9ADwROCMZ3CfldMCMPqAt0QJXWMFeeX4WdKxVpxOkK33u8xJjLwazRimNJESXWDknQHUeFsWXVD5Icmd20NkW3yqO27LPw-KpuoCyjdvM9nadS50lZ36KqwlYf78x2jj-Uina_i9ebldT5bxxmnIlQzJgRgvJVaUymkBrbNVA6KQgacYU4sx0VGuZCJ1kpSC4EmQmDCWKIFG6OnU-7BtZ89-M7Upc-gqmwDbe8NJVgzKkNLoM8nmrnWeweFObiytm4wBJvjSua4kjmuFOzjObbf1pD_yd9ZApiewFdZwfB_klm8rZY_kd8AaW4i</recordid><startdate>201811</startdate><enddate>201811</enddate><creator>Sanders, Natalie A.</creator><creator>Supiano, Mark A.</creator><creator>Lewis, Eldrin F.</creator><creator>Liu, Jiankang</creator><creator>Claggett, Brian</creator><creator>Pfeffer, Marc A.</creator><creator>Desai, Akshay S.</creator><creator>Sweitzer, Nancy K.</creator><creator>Solomon, Scott D.</creator><creator>Fang, James C.</creator><general>John Wiley & Sons, Ltd</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>7X8</scope></search><sort><creationdate>201811</creationdate><title>The frailty syndrome and outcomes in the TOPCAT trial</title><author>Sanders, Natalie A. ; Supiano, Mark A. ; Lewis, Eldrin F. ; Liu, Jiankang ; Claggett, Brian ; Pfeffer, Marc A. ; Desai, Akshay S. ; Sweitzer, Nancy K. ; Solomon, Scott D. ; Fang, James C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4268-93366e00b79927679e3bc8de82ece43041a40fc2467599872aeb7956601335963</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aged</topic><topic>Americas - epidemiology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Frail Elderly</topic><topic>Frailty</topic><topic>Frailty - complications</topic><topic>Frailty - mortality</topic><topic>Frailty - physiopathology</topic><topic>Georgia (Republic) - epidemiology</topic><topic>Heart Failure - complications</topic><topic>Heart Failure - drug therapy</topic><topic>Heart Failure - physiopathology</topic><topic>Heart failure with preserved ejection fraction</topic><topic>Humans</topic><topic>Male</topic><topic>Mineralocorticoid Receptor Antagonists - therapeutic use</topic><topic>Outcomes</topic><topic>Russia - epidemiology</topic><topic>Spironolactone - therapeutic use</topic><topic>Stroke Volume - physiology</topic><topic>Survival Rate - trends</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sanders, Natalie A.</creatorcontrib><creatorcontrib>Supiano, Mark A.</creatorcontrib><creatorcontrib>Lewis, Eldrin F.</creatorcontrib><creatorcontrib>Liu, Jiankang</creatorcontrib><creatorcontrib>Claggett, Brian</creatorcontrib><creatorcontrib>Pfeffer, Marc A.</creatorcontrib><creatorcontrib>Desai, Akshay S.</creatorcontrib><creatorcontrib>Sweitzer, Nancy K.</creatorcontrib><creatorcontrib>Solomon, Scott D.</creatorcontrib><creatorcontrib>Fang, James C.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of heart failure</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sanders, Natalie A.</au><au>Supiano, Mark A.</au><au>Lewis, Eldrin F.</au><au>Liu, Jiankang</au><au>Claggett, Brian</au><au>Pfeffer, Marc A.</au><au>Desai, Akshay S.</au><au>Sweitzer, Nancy K.</au><au>Solomon, Scott D.</au><au>Fang, James C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The frailty syndrome and outcomes in the TOPCAT trial</atitle><jtitle>European journal of heart failure</jtitle><addtitle>Eur J Heart Fail</addtitle><date>2018-11</date><risdate>2018</risdate><volume>20</volume><issue>11</issue><spage>1570</spage><epage>1577</epage><pages>1570-1577</pages><issn>1388-9842</issn><eissn>1879-0844</eissn><abstract>Aims
The impact of frailty on outcomes in randomized heart failure with preserved ejection fraction (HFpEF) trials has not been previously reported. This analysis sought to characterize frailty in a large contemporary HFpEF clinical trial cohort and to evaluate its impact on patient relevant outcomes.
Methods and results
Using data from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, a frailty index (FI) was constructed at baseline using 39 clinical, laboratory, and self‐reported variables. The relationship between frailty and outcomes and the role of frailty in modulating the benefits of spironolactone were examined in a subset of 1767 TOPCAT patients. For the cohort as a whole (mean age 71.5 years, 49% female), the mean FI at baseline was 0.37 ± 0.11. Four frailty classes were defined ranging from FI < 0.3 to FI ≥ 0.5. Overall, 94% of subjects were considered frail (defined as a FI > 0.21). Mean age was lowest for the most frail class (69 ± 9 years for Class 4; 73 ± 10 years for Class 1; P < 0.001). Body mass index, systolic blood pressure, and pulse pressure all increased as FI increased. Both primary and secondary outcomes increased as frailty severity increased. There was no interaction between frailty class and treatment effect of spironolactone.
Conclusions
Frailty was very common in TOPCAT HFpEF participants. Greater frailty was associated with a higher risk of cardiovascular outcomes and mortality. The benefit of spironolactone on outcomes in TOPCAT was not attenuated by frailty class.</abstract><cop>Oxford, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>30225878</pmid><doi>10.1002/ejhf.1308</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | European journal of heart failure, 2018-11, Vol.20 (11), p.1570-1577 |
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| source | Wiley Free Content; MEDLINE; Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Aged Americas - epidemiology Double-Blind Method Female Frail Elderly Frailty Frailty - complications Frailty - mortality Frailty - physiopathology Georgia (Republic) - epidemiology Heart Failure - complications Heart Failure - drug therapy Heart Failure - physiopathology Heart failure with preserved ejection fraction Humans Male Mineralocorticoid Receptor Antagonists - therapeutic use Outcomes Russia - epidemiology Spironolactone - therapeutic use Stroke Volume - physiology Survival Rate - trends Treatment Outcome |
| title | The frailty syndrome and outcomes in the TOPCAT trial |
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