What Type of Patients Did PARAGON-HF Select? Insights from a Real-World Prospective Cohort of Patients with Heart Failure and Preserved Ejection Fraction

The PARAGON-HF clinical trial suggested that sacubitril/valsartan may become a treatment option for particular subgroups of patients with heart failure and preserved ejection fraction (HFpEF). However, the proportion of real-world HFpEF patients who are theoretically superimposable with the PARAGON-...

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Veröffentlicht in:Journal of clinical medicine 2020-11, Vol.9 (11), p.3669
Hauptverfasser: Rettl, René, Dachs, Theresa-Marie, Duca, Franz, Binder, Christina, Dusik, Fabian, Seirer, Benjamin, Schönauer, Johannes, Kronberger, Christina, Camuz Ligios, Luciana, Hengstenberg, Christian, Derkits, Nina, Kastner, Johannes, Badr Eslam, Roza, Bonderman, Diana
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container_issue 11
container_start_page 3669
container_title Journal of clinical medicine
container_volume 9
creator Rettl, René
Dachs, Theresa-Marie
Duca, Franz
Binder, Christina
Dusik, Fabian
Seirer, Benjamin
Schönauer, Johannes
Kronberger, Christina
Camuz Ligios, Luciana
Hengstenberg, Christian
Derkits, Nina
Kastner, Johannes
Badr Eslam, Roza
Bonderman, Diana
description The PARAGON-HF clinical trial suggested that sacubitril/valsartan may become a treatment option for particular subgroups of patients with heart failure and preserved ejection fraction (HFpEF). However, the proportion of real-world HFpEF patients who are theoretically superimposable with the PARAGON-HF population is yet unknown. The present study was performed to define the proportion of real-world PARAGON-HF-like patients and to describe their clinical characteristics and long-term prognosis in comparison with those who would not meet PARAGON-HF criteria. We systematically applied PARAGON-HF inclusion and exclusion criteria to a total of 427 HFpEF patients who have been participating in a prospective national registry between December 2010 and December 2019. In total, only 170 (39.8%) registry patients were theoretically eligible for PARAGON-HF. Patients not meeting inclusion criteria (41.0%) were less impaired with respect to exercise capacity (median 6-min walk distance: 385 m (IQR: 300–450) versus 323 m (IQR: 240–383); p < 0.001) had lower pulmonary pressures (mean pulmonary artery pressure (mPAP): 31.2 mmHg, standard deviation (SD): ±10.2 versus 32.8 mmHg, SD: ±9.7; p < 0.001) and better outcomes (log-rank: p < 0.001) as compared to the PARAGON-like cohort. However, patients theoretically excluded from the trial (19.2%) were those with most advanced heart failure symptoms (median 6-min walk test: 252 m (IQR: 165–387); p < 0.001), highest pulmonary pressures (mPAP: 38.2 mmHg, SD: ±12.4; p < 0.001) and worst outcome (log-rank: p = 0.037). We demonstrate here that < 40% of real-world HFpEF patients meet eligibility criteria for PARAGON-HF. We conclude that despite reasons for optimism after PARAGON-HF, a large proportion of HFpEF patients will remain without meaningful treatment options.
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Insights from a Real-World Prospective Cohort of Patients with Heart Failure and Preserved Ejection Fraction</title><source>PubMed Central Open Access</source><source>MDPI - Multidisciplinary Digital Publishing Institute</source><source>EZB-FREE-00999 freely available EZB journals</source><source>PubMed Central</source><creator>Rettl, René ; Dachs, Theresa-Marie ; Duca, Franz ; Binder, Christina ; Dusik, Fabian ; Seirer, Benjamin ; Schönauer, Johannes ; Kronberger, Christina ; Camuz Ligios, Luciana ; Hengstenberg, Christian ; Derkits, Nina ; Kastner, Johannes ; Badr Eslam, Roza ; Bonderman, Diana</creator><creatorcontrib>Rettl, René ; Dachs, Theresa-Marie ; Duca, Franz ; Binder, Christina ; Dusik, Fabian ; Seirer, Benjamin ; Schönauer, Johannes ; Kronberger, Christina ; Camuz Ligios, Luciana ; Hengstenberg, Christian ; Derkits, Nina ; Kastner, Johannes ; Badr Eslam, Roza ; Bonderman, Diana</creatorcontrib><description><![CDATA[The PARAGON-HF clinical trial suggested that sacubitril/valsartan may become a treatment option for particular subgroups of patients with heart failure and preserved ejection fraction (HFpEF). However, the proportion of real-world HFpEF patients who are theoretically superimposable with the PARAGON-HF population is yet unknown. The present study was performed to define the proportion of real-world PARAGON-HF-like patients and to describe their clinical characteristics and long-term prognosis in comparison with those who would not meet PARAGON-HF criteria. We systematically applied PARAGON-HF inclusion and exclusion criteria to a total of 427 HFpEF patients who have been participating in a prospective national registry between December 2010 and December 2019. In total, only 170 (39.8%) registry patients were theoretically eligible for PARAGON-HF. Patients not meeting inclusion criteria (41.0%) were less impaired with respect to exercise capacity (median 6-min walk distance: 385 m (IQR: 300–450) versus 323 m (IQR: 240–383); p < 0.001) had lower pulmonary pressures (mean pulmonary artery pressure (mPAP): 31.2 mmHg, standard deviation (SD): ±10.2 versus 32.8 mmHg, SD: ±9.7; p < 0.001) and better outcomes (log-rank: p < 0.001) as compared to the PARAGON-like cohort. However, patients theoretically excluded from the trial (19.2%) were those with most advanced heart failure symptoms (median 6-min walk test: 252 m (IQR: 165–387); p < 0.001), highest pulmonary pressures (mPAP: 38.2 mmHg, SD: ±12.4; p < 0.001) and worst outcome (log-rank: p = 0.037). We demonstrate here that < 40% of real-world HFpEF patients meet eligibility criteria for PARAGON-HF. We conclude that despite reasons for optimism after PARAGON-HF, a large proportion of HFpEF patients will remain without meaningful treatment options.]]></description><identifier>ISSN: 2077-0383</identifier><identifier>EISSN: 2077-0383</identifier><identifier>DOI: 10.3390/jcm9113669</identifier><identifier>PMID: 33203151</identifier><language>eng</language><publisher>Basel: MDPI AG</publisher><subject>Cardiology ; Cardiovascular disease ; Clinical medicine ; Clinical outcomes ; Ejection fraction ; Females ; Genotype &amp; phenotype ; Heart failure ; Hospitalization ; Hypertension ; Laboratories ; Pathophysiology ; Patient safety ; Pulmonary arteries ; Variance analysis</subject><ispartof>Journal of clinical medicine, 2020-11, Vol.9 (11), p.3669</ispartof><rights>2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). 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In total, only 170 (39.8%) registry patients were theoretically eligible for PARAGON-HF. Patients not meeting inclusion criteria (41.0%) were less impaired with respect to exercise capacity (median 6-min walk distance: 385 m (IQR: 300–450) versus 323 m (IQR: 240–383); p < 0.001) had lower pulmonary pressures (mean pulmonary artery pressure (mPAP): 31.2 mmHg, standard deviation (SD): ±10.2 versus 32.8 mmHg, SD: ±9.7; p < 0.001) and better outcomes (log-rank: p < 0.001) as compared to the PARAGON-like cohort. However, patients theoretically excluded from the trial (19.2%) were those with most advanced heart failure symptoms (median 6-min walk test: 252 m (IQR: 165–387); p < 0.001), highest pulmonary pressures (mPAP: 38.2 mmHg, SD: ±12.4; p < 0.001) and worst outcome (log-rank: p = 0.037). We demonstrate here that < 40% of real-world HFpEF patients meet eligibility criteria for PARAGON-HF. We conclude that despite reasons for optimism after PARAGON-HF, a large proportion of HFpEF patients will remain without meaningful treatment options.]]></description><subject>Cardiology</subject><subject>Cardiovascular disease</subject><subject>Clinical medicine</subject><subject>Clinical outcomes</subject><subject>Ejection fraction</subject><subject>Females</subject><subject>Genotype &amp; phenotype</subject><subject>Heart failure</subject><subject>Hospitalization</subject><subject>Hypertension</subject><subject>Laboratories</subject><subject>Pathophysiology</subject><subject>Patient safety</subject><subject>Pulmonary arteries</subject><subject>Variance analysis</subject><issn>2077-0383</issn><issn>2077-0383</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNpdkc1u1DAQxyMEolXphSewxAUhBfwRO_EFtFq63UoVrUpRj9bEmTReJfFiJ4v6KH3bemkFlLnMaOY3f81Hlr1l9KMQmn7a2EEzJpTSL7JDTssyp6ISL_-JD7LjGDc0WVUVnJWvswMhOBVMssPs_qaDiVzfbZH4llzC5HCcIvnqGnK5uFqcXnzL1yvyHXu00xdyNkZ326V6G_xAgFwh9PmND32ig4_bBLkdkqXvfJieCf5yU0fWCCm9AtfPAQmM-y6MGHbYkJPNvtmPZBXgd_Ame9VCH_H4yR9lP1Yn18t1fn5xerZcnOc27TblUkBtLcrGcl6witdaqVJhQ9FKJcumQpFyCLpFoSFhrKqhFii5pkxbEEfZ50fd7VwP2Ng0boDebIMbINwZD848r4yuM7d-Z0qlS0lZEnj_JBD8zxnjZAYXLfY9jOjnaHihWKWYKPbou__QjZ_DmNYzXBWMSialTNSHR8qmm8aA7Z9hGDX7p5u_TxcPu3ye7A</recordid><startdate>20201115</startdate><enddate>20201115</enddate><creator>Rettl, René</creator><creator>Dachs, Theresa-Marie</creator><creator>Duca, Franz</creator><creator>Binder, Christina</creator><creator>Dusik, Fabian</creator><creator>Seirer, Benjamin</creator><creator>Schönauer, Johannes</creator><creator>Kronberger, Christina</creator><creator>Camuz Ligios, Luciana</creator><creator>Hengstenberg, Christian</creator><creator>Derkits, Nina</creator><creator>Kastner, Johannes</creator><creator>Badr Eslam, Roza</creator><creator>Bonderman, Diana</creator><general>MDPI AG</general><general>MDPI</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-6060-7910</orcidid><orcidid>https://orcid.org/0000-0002-5169-8707</orcidid><orcidid>https://orcid.org/0000-0002-7519-5274</orcidid><orcidid>https://orcid.org/0000-0001-6409-5158</orcidid></search><sort><creationdate>20201115</creationdate><title>What Type of Patients Did PARAGON-HF Select? 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subjects Cardiology
Cardiovascular disease
Clinical medicine
Clinical outcomes
Ejection fraction
Females
Genotype & phenotype
Heart failure
Hospitalization
Hypertension
Laboratories
Pathophysiology
Patient safety
Pulmonary arteries
Variance analysis
title What Type of Patients Did PARAGON-HF Select? Insights from a Real-World Prospective Cohort of Patients with Heart Failure and Preserved Ejection Fraction
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