Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure
U.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe and effective in EF >40% after a worsening heart failure (WHF) event is unknown. PARAGLIDE-HF (Prospective comparison of...
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| Veröffentlicht in: | Journal of the American College of Cardiology 2023-07, Vol.82 (1), p.1-12 |
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| creator | Mentz, Robert J. Ward, Jonathan H. Hernandez, Adrian F. Lepage, Serge Morrow, David A. Sarwat, Samiha Sharma, Kavita Starling, Randall C. Velazquez, Eric J. Williamson, Kristin M. Desai, Akshay S. Zieroth, Shelley Solomon, Scott D. Braunwald, Eugene |
| description | U.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe and effective in EF >40% after a worsening heart failure (WHF) event is unknown.
PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed sacubitril/valsartan vs valsartan in EF >40% following a recent WHF event.
PARAGLIDE-HF is a double-blind, randomized controlled trial of sacubitril/valsartan vs valsartan in patients with EF >40% enrolled within 30 days of a WHF event. The primary endpoint was time-averaged proportional change in amino terminal pro–B-type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. A secondary hierarchical outcome (win ratio) consisted of: 1) cardiovascular death; 2) HF hospitalizations; 3) urgent HF visits; and 4) change in NT-proBNP.
In 466 patients (233 sacubitril/valsartan; 233 valsartan), time-averaged reduction in the NT-proBNP was greater with sacubitril/valsartan (ratio of change: 0.85; 95% CI: 0.73-0.999; P = 0.049). The hierarchical outcome favored sacubitril/valsartan but was not significant (unmatched win ratio: 1.19; 95% CI: 0.93-1.52; P = 0.16). Sacubitril/valsartan reduced worsening renal function (OR: 0.61; 95% CI: 0.40-0.93) but increased symptomatic hypotension (OR: 1.73; 95% CI: 1.09-2.76). There was evidence of a larger treatment effect in the subgroup with EF ≤60% for NT-proBNP change (0.78; 95% CI: 0.61-0.98) and the hierarchical outcome (win ratio: 1.46; 95% CI: 1.09-1.95).
Among patients with EF >40% stabilized after WHF, sacubitril/valsartan led to greater reduction in plasma NT-proBNP levels and was associated with clinical benefit compared with valsartan alone, despite more symptomatic hypotension. (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634)
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| doi_str_mv | 10.1016/j.jacc.2023.04.019 |
| format | Article |
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PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed sacubitril/valsartan vs valsartan in EF >40% following a recent WHF event.
PARAGLIDE-HF is a double-blind, randomized controlled trial of sacubitril/valsartan vs valsartan in patients with EF >40% enrolled within 30 days of a WHF event. The primary endpoint was time-averaged proportional change in amino terminal pro–B-type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. A secondary hierarchical outcome (win ratio) consisted of: 1) cardiovascular death; 2) HF hospitalizations; 3) urgent HF visits; and 4) change in NT-proBNP.
In 466 patients (233 sacubitril/valsartan; 233 valsartan), time-averaged reduction in the NT-proBNP was greater with sacubitril/valsartan (ratio of change: 0.85; 95% CI: 0.73-0.999; P = 0.049). The hierarchical outcome favored sacubitril/valsartan but was not significant (unmatched win ratio: 1.19; 95% CI: 0.93-1.52; P = 0.16). Sacubitril/valsartan reduced worsening renal function (OR: 0.61; 95% CI: 0.40-0.93) but increased symptomatic hypotension (OR: 1.73; 95% CI: 1.09-2.76). There was evidence of a larger treatment effect in the subgroup with EF ≤60% for NT-proBNP change (0.78; 95% CI: 0.61-0.98) and the hierarchical outcome (win ratio: 1.46; 95% CI: 1.09-1.95).
Among patients with EF >40% stabilized after WHF, sacubitril/valsartan led to greater reduction in plasma NT-proBNP levels and was associated with clinical benefit compared with valsartan alone, despite more symptomatic hypotension. (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634)
[Display omitted]</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2023.04.019</identifier><identifier>PMID: 37212758</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>acute decompensated HFpEF ; Aminobutyrates - pharmacology ; Aminobutyrates - therapeutic use ; Angiotensin Receptor Antagonists - pharmacology ; Angiotensin Receptor Antagonists - therapeutic use ; Angiotensin-Converting Enzyme Inhibitors - therapeutic use ; Angiotensins - pharmacology ; Angiotensins - therapeutic use ; Biphenyl Compounds - therapeutic use ; clinical outcomes ; Drug Combinations ; Heart Failure ; HFmrEF ; Humans ; Hypotension - chemically induced ; Hypotension - drug therapy ; natriuretic peptides ; Neprilysin - therapeutic use ; sacubitril/valsartan ; Stroke Volume ; Tetrazoles - pharmacology ; Tetrazoles - therapeutic use ; Valsartan - therapeutic use</subject><ispartof>Journal of the American College of Cardiology, 2023-07, Vol.82 (1), p.1-12</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023 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-c400t-a2b1c11865982629a9fcd747f04936a8922f418e36e33a8ed25b52b6894af6e93</citedby><cites>FETCH-LOGICAL-c400t-a2b1c11865982629a9fcd747f04936a8922f418e36e33a8ed25b52b6894af6e93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0735109723054293$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37212758$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mentz, Robert J.</creatorcontrib><creatorcontrib>Ward, Jonathan H.</creatorcontrib><creatorcontrib>Hernandez, Adrian F.</creatorcontrib><creatorcontrib>Lepage, Serge</creatorcontrib><creatorcontrib>Morrow, David A.</creatorcontrib><creatorcontrib>Sarwat, Samiha</creatorcontrib><creatorcontrib>Sharma, Kavita</creatorcontrib><creatorcontrib>Starling, Randall C.</creatorcontrib><creatorcontrib>Velazquez, Eric J.</creatorcontrib><creatorcontrib>Williamson, Kristin M.</creatorcontrib><creatorcontrib>Desai, Akshay S.</creatorcontrib><creatorcontrib>Zieroth, Shelley</creatorcontrib><creatorcontrib>Solomon, Scott D.</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>PARAGLIDE-HF Investigators</creatorcontrib><title>Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>U.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe and effective in EF >40% after a worsening heart failure (WHF) event is unknown.
PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed sacubitril/valsartan vs valsartan in EF >40% following a recent WHF event.
PARAGLIDE-HF is a double-blind, randomized controlled trial of sacubitril/valsartan vs valsartan in patients with EF >40% enrolled within 30 days of a WHF event. The primary endpoint was time-averaged proportional change in amino terminal pro–B-type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. A secondary hierarchical outcome (win ratio) consisted of: 1) cardiovascular death; 2) HF hospitalizations; 3) urgent HF visits; and 4) change in NT-proBNP.
In 466 patients (233 sacubitril/valsartan; 233 valsartan), time-averaged reduction in the NT-proBNP was greater with sacubitril/valsartan (ratio of change: 0.85; 95% CI: 0.73-0.999; P = 0.049). The hierarchical outcome favored sacubitril/valsartan but was not significant (unmatched win ratio: 1.19; 95% CI: 0.93-1.52; P = 0.16). Sacubitril/valsartan reduced worsening renal function (OR: 0.61; 95% CI: 0.40-0.93) but increased symptomatic hypotension (OR: 1.73; 95% CI: 1.09-2.76). There was evidence of a larger treatment effect in the subgroup with EF ≤60% for NT-proBNP change (0.78; 95% CI: 0.61-0.98) and the hierarchical outcome (win ratio: 1.46; 95% CI: 1.09-1.95).
Among patients with EF >40% stabilized after WHF, sacubitril/valsartan led to greater reduction in plasma NT-proBNP levels and was associated with clinical benefit compared with valsartan alone, despite more symptomatic hypotension. (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634)
[Display omitted]</description><subject>acute decompensated HFpEF</subject><subject>Aminobutyrates - pharmacology</subject><subject>Aminobutyrates - therapeutic use</subject><subject>Angiotensin Receptor Antagonists - pharmacology</subject><subject>Angiotensin Receptor Antagonists - therapeutic use</subject><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</subject><subject>Angiotensins - pharmacology</subject><subject>Angiotensins - therapeutic use</subject><subject>Biphenyl Compounds - therapeutic use</subject><subject>clinical outcomes</subject><subject>Drug Combinations</subject><subject>Heart Failure</subject><subject>HFmrEF</subject><subject>Humans</subject><subject>Hypotension - chemically induced</subject><subject>Hypotension - drug therapy</subject><subject>natriuretic peptides</subject><subject>Neprilysin - therapeutic use</subject><subject>sacubitril/valsartan</subject><subject>Stroke Volume</subject><subject>Tetrazoles - pharmacology</subject><subject>Tetrazoles - therapeutic use</subject><subject>Valsartan - therapeutic use</subject><issn>0735-1097</issn><issn>1558-3597</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kM1O3DAURi3UCqbAC7CosuwmwT9xbEvdIMQUJCioKpql5Tg34CjjUDtBmh2PMs8yT4aHmXbZ1b1XOt8n3YPQGcEFwaQ674rOWFtQTFmBywITdYBmhHOZM67EJzTDgvGcYCWO0JcYO4xxJYk6REdMUEIFlzP0duGf3DCCj87nP-EluH6V1uzGP7vajW7wmfOb9YMZHfgxZgs3Pmd3rm_6VfYLmslCkw0hAQEihNd0XXVgP3LzYHaL8c1mvRhCBO_8U3YNJoyb9dy4fgpwgj63po9wup_H6HF-9fvyOr-9_3FzeXGb2xLjMTe0JpYQWXElaUWVUa1tRClaXCpWGakobUsigVXAmJHQUF5zWldSlaatQLFj9G3X-xKGPxPEUS9dtND3xsMwRU0lEUJwRXhC6Q61YYgxQKuTlqUJK02w3prXnd6a11vzGpc6mU-hr_v-qV5C8y_yV3UCvu8ASF--Ogg62uQ0CXQhGdPN4P7X_w5xu5lD</recordid><startdate>20230704</startdate><enddate>20230704</enddate><creator>Mentz, Robert J.</creator><creator>Ward, Jonathan H.</creator><creator>Hernandez, Adrian F.</creator><creator>Lepage, Serge</creator><creator>Morrow, David A.</creator><creator>Sarwat, Samiha</creator><creator>Sharma, Kavita</creator><creator>Starling, Randall C.</creator><creator>Velazquez, Eric J.</creator><creator>Williamson, Kristin M.</creator><creator>Desai, Akshay S.</creator><creator>Zieroth, Shelley</creator><creator>Solomon, Scott D.</creator><creator>Braunwald, Eugene</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><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>20230704</creationdate><title>Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure</title><author>Mentz, Robert J. ; Ward, Jonathan H. ; Hernandez, Adrian F. ; Lepage, Serge ; Morrow, David A. ; Sarwat, Samiha ; Sharma, Kavita ; Starling, Randall C. ; Velazquez, Eric J. ; Williamson, Kristin M. ; Desai, Akshay S. ; Zieroth, Shelley ; Solomon, Scott D. ; Braunwald, Eugene</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c400t-a2b1c11865982629a9fcd747f04936a8922f418e36e33a8ed25b52b6894af6e93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>acute decompensated HFpEF</topic><topic>Aminobutyrates - pharmacology</topic><topic>Aminobutyrates - therapeutic use</topic><topic>Angiotensin Receptor Antagonists - pharmacology</topic><topic>Angiotensin Receptor Antagonists - therapeutic use</topic><topic>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</topic><topic>Angiotensins - pharmacology</topic><topic>Angiotensins - therapeutic use</topic><topic>Biphenyl Compounds - therapeutic use</topic><topic>clinical outcomes</topic><topic>Drug Combinations</topic><topic>Heart Failure</topic><topic>HFmrEF</topic><topic>Humans</topic><topic>Hypotension - chemically induced</topic><topic>Hypotension - drug therapy</topic><topic>natriuretic peptides</topic><topic>Neprilysin - therapeutic use</topic><topic>sacubitril/valsartan</topic><topic>Stroke Volume</topic><topic>Tetrazoles - pharmacology</topic><topic>Tetrazoles - therapeutic use</topic><topic>Valsartan - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mentz, Robert J.</creatorcontrib><creatorcontrib>Ward, Jonathan H.</creatorcontrib><creatorcontrib>Hernandez, Adrian F.</creatorcontrib><creatorcontrib>Lepage, Serge</creatorcontrib><creatorcontrib>Morrow, David A.</creatorcontrib><creatorcontrib>Sarwat, Samiha</creatorcontrib><creatorcontrib>Sharma, Kavita</creatorcontrib><creatorcontrib>Starling, Randall C.</creatorcontrib><creatorcontrib>Velazquez, Eric J.</creatorcontrib><creatorcontrib>Williamson, Kristin M.</creatorcontrib><creatorcontrib>Desai, Akshay S.</creatorcontrib><creatorcontrib>Zieroth, Shelley</creatorcontrib><creatorcontrib>Solomon, Scott D.</creatorcontrib><creatorcontrib>Braunwald, Eugene</creatorcontrib><creatorcontrib>PARAGLIDE-HF Investigators</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>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mentz, Robert J.</au><au>Ward, Jonathan H.</au><au>Hernandez, Adrian F.</au><au>Lepage, Serge</au><au>Morrow, David A.</au><au>Sarwat, Samiha</au><au>Sharma, Kavita</au><au>Starling, Randall C.</au><au>Velazquez, Eric J.</au><au>Williamson, Kristin M.</au><au>Desai, Akshay S.</au><au>Zieroth, Shelley</au><au>Solomon, Scott D.</au><au>Braunwald, Eugene</au><aucorp>PARAGLIDE-HF Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2023-07-04</date><risdate>2023</risdate><volume>82</volume><issue>1</issue><spage>1</spage><epage>12</epage><pages>1-12</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><abstract>U.S. guidelines recommend consideration of sacubitril/valsartan in chronic heart failure (HF) and mildly reduced or preserved ejection fraction (EF). Whether initiation is safe and effective in EF >40% after a worsening heart failure (WHF) event is unknown.
PARAGLIDE-HF (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF) assessed sacubitril/valsartan vs valsartan in EF >40% following a recent WHF event.
PARAGLIDE-HF is a double-blind, randomized controlled trial of sacubitril/valsartan vs valsartan in patients with EF >40% enrolled within 30 days of a WHF event. The primary endpoint was time-averaged proportional change in amino terminal pro–B-type natriuretic peptide (NT-proBNP) from baseline through Weeks 4 and 8. A secondary hierarchical outcome (win ratio) consisted of: 1) cardiovascular death; 2) HF hospitalizations; 3) urgent HF visits; and 4) change in NT-proBNP.
In 466 patients (233 sacubitril/valsartan; 233 valsartan), time-averaged reduction in the NT-proBNP was greater with sacubitril/valsartan (ratio of change: 0.85; 95% CI: 0.73-0.999; P = 0.049). The hierarchical outcome favored sacubitril/valsartan but was not significant (unmatched win ratio: 1.19; 95% CI: 0.93-1.52; P = 0.16). Sacubitril/valsartan reduced worsening renal function (OR: 0.61; 95% CI: 0.40-0.93) but increased symptomatic hypotension (OR: 1.73; 95% CI: 1.09-2.76). There was evidence of a larger treatment effect in the subgroup with EF ≤60% for NT-proBNP change (0.78; 95% CI: 0.61-0.98) and the hierarchical outcome (win ratio: 1.46; 95% CI: 1.09-1.95).
Among patients with EF >40% stabilized after WHF, sacubitril/valsartan led to greater reduction in plasma NT-proBNP levels and was associated with clinical benefit compared with valsartan alone, despite more symptomatic hypotension. (Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF; NCT03988634)
[Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>37212758</pmid><doi>10.1016/j.jacc.2023.04.019</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; Elsevier ScienceDirect Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | acute decompensated HFpEF Aminobutyrates - pharmacology Aminobutyrates - therapeutic use Angiotensin Receptor Antagonists - pharmacology Angiotensin Receptor Antagonists - therapeutic use Angiotensin-Converting Enzyme Inhibitors - therapeutic use Angiotensins - pharmacology Angiotensins - therapeutic use Biphenyl Compounds - therapeutic use clinical outcomes Drug Combinations Heart Failure HFmrEF Humans Hypotension - chemically induced Hypotension - drug therapy natriuretic peptides Neprilysin - therapeutic use sacubitril/valsartan Stroke Volume Tetrazoles - pharmacology Tetrazoles - therapeutic use Valsartan - therapeutic use |
| title | Angiotensin-Neprilysin Inhibition in Patients With Mildly Reduced or Preserved Ejection Fraction and Worsening Heart Failure |
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