Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.

AIMS: This study aimed to evaluate the effect of dapagliflozin on 1 and 3-month maximal functional capacity in patients with stable heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: In this multicentre, randomized, double-blind clinical trial, 90 stable patients with HFrEF w...

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Autores: Palau, P, Amiguet, M, Dominguez, E, Sastre, C, Mollar, A, Seller, J, Pinilla, JMG, Larumbe, A, Valle, A, Doblas, JJG, de la Espriella, R, Minana, G, Mezcua, AR, Santas, E, Bodi, V, Sanchis, J, Pascual-Figal, D, Gorriz, JL, Bayes-Genis, A, Nunez, J
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Recursos:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p16599
Acesso em linha:https://incliva.portalinvestigacion.com/publicaciones/16599
Access Level:acceso abierto
Palavra-chave:Dapagliflozin
Heart failure with reduced ejection fraction
Maximal functional capacity
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spelling Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.Palau, PAmiguet, MDominguez, ESastre, CMollar, ASeller, JPinilla, JMGLarumbe, AValle, ADoblas, JJGde la Espriella, RMinana, GMezcua, ARSantas, EBodi, VSanchis, JPascual-Figal, DGorriz, JLBayes-Genis, ANunez, JDapagliflozinHeart failure with reduced ejection fractionMaximal functional capacityAIMS: This study aimed to evaluate the effect of dapagliflozin on 1 and 3-month maximal functional capacity in patients with stable heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: In this multicentre, randomized, double-blind clinical trial, 90 stable patients with HFrEF were randomly assigned to receive either dapagliflozin (n = 45) or placebo (n = 45). The primary outcome was a change in peak oxygen consumption (peakVO(2) ) at 1 and 3 months. Secondary endpoints were changes at 1 and 3 months in 6-min walk test (6MWT) distance, quality of life (Minnesota Living with Heart Failure Questionnaire [MLHFQ]), and echocardiographic parameters (diastolic function, left chamber volumes, and left ventricular ejection fraction). We used linear mixed regression analysis to compare endpoint changes. Estimates were adjusted for multiple comparisons. The mean age was 67.1 ± 10.7 years, 69 (76.7%) were men, 29 (32.2%) had type 2 diabetes, and 80 (88.9%) were in New York Heart Association class II. Baseline means of peakVO(2) , 6MWT and MLHFQ were 13.2 ± 3.5 ml/kg/min, 363 ± 110 m, and 23.1 ± 16.2, respectively. The median (25th-75th percentile) of N-terminal pro-brain natriuretic peptide was 1221 pg/ml (889-2100). Most patients were on treatment with sacubitril/valsartan (88.9%), beta-blockers (91.1%), and mineralocorticoid receptor antagonists (74.4%). PeakVO(2) significantly increased in patients on treatment with dapagliflozin (1 month: + 1.09 ml/kg/min, 95% confidence interval [CI] 0.14-2.04; p = 0.021, and 3 months: + 1.06 ml/kg/min, 95% CI 0.07-2.04; p = 0.032). Similar positive findings were found when evaluating changes from baseline. No significant differences were observed in secondary endpoints. CONCLUSIONS: Among patients with stable HFrEF, dapagliflozin resulted in a significant improvement in peakVO(2) at 1 and 3 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04197635.WILEY2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/16599EUROPEAN JOURNAL OF HEART FAILUREISSN: 13889842ISSNe: 18790844reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p165992026-06-07T16:35:31Z
dc.title.none.fl_str_mv Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
title Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
spellingShingle Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
Palau, P
Dapagliflozin
Heart failure with reduced ejection fraction
Maximal functional capacity
title_short Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
title_full Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
title_fullStr Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
title_full_unstemmed Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
title_sort Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.
dc.creator.none.fl_str_mv Palau, P
Amiguet, M
Dominguez, E
Sastre, C
Mollar, A
Seller, J
Pinilla, JMG
Larumbe, A
Valle, A
Doblas, JJG
de la Espriella, R
Minana, G
Mezcua, AR
Santas, E
Bodi, V
Sanchis, J
Pascual-Figal, D
Gorriz, JL
Bayes-Genis, A
Nunez, J
author Palau, P
author_facet Palau, P
Amiguet, M
Dominguez, E
Sastre, C
Mollar, A
Seller, J
Pinilla, JMG
Larumbe, A
Valle, A
Doblas, JJG
de la Espriella, R
Minana, G
Mezcua, AR
Santas, E
Bodi, V
Sanchis, J
Pascual-Figal, D
Gorriz, JL
Bayes-Genis, A
Nunez, J
author_role author
author2 Amiguet, M
Dominguez, E
Sastre, C
Mollar, A
Seller, J
Pinilla, JMG
Larumbe, A
Valle, A
Doblas, JJG
de la Espriella, R
Minana, G
Mezcua, AR
Santas, E
Bodi, V
Sanchis, J
Pascual-Figal, D
Gorriz, JL
Bayes-Genis, A
Nunez, J
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Dapagliflozin
Heart failure with reduced ejection fraction
Maximal functional capacity
topic Dapagliflozin
Heart failure with reduced ejection fraction
Maximal functional capacity
description AIMS: This study aimed to evaluate the effect of dapagliflozin on 1 and 3-month maximal functional capacity in patients with stable heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: In this multicentre, randomized, double-blind clinical trial, 90 stable patients with HFrEF were randomly assigned to receive either dapagliflozin (n = 45) or placebo (n = 45). The primary outcome was a change in peak oxygen consumption (peakVO(2) ) at 1 and 3 months. Secondary endpoints were changes at 1 and 3 months in 6-min walk test (6MWT) distance, quality of life (Minnesota Living with Heart Failure Questionnaire [MLHFQ]), and echocardiographic parameters (diastolic function, left chamber volumes, and left ventricular ejection fraction). We used linear mixed regression analysis to compare endpoint changes. Estimates were adjusted for multiple comparisons. The mean age was 67.1 ± 10.7 years, 69 (76.7%) were men, 29 (32.2%) had type 2 diabetes, and 80 (88.9%) were in New York Heart Association class II. Baseline means of peakVO(2) , 6MWT and MLHFQ were 13.2 ± 3.5 ml/kg/min, 363 ± 110 m, and 23.1 ± 16.2, respectively. The median (25th-75th percentile) of N-terminal pro-brain natriuretic peptide was 1221 pg/ml (889-2100). Most patients were on treatment with sacubitril/valsartan (88.9%), beta-blockers (91.1%), and mineralocorticoid receptor antagonists (74.4%). PeakVO(2) significantly increased in patients on treatment with dapagliflozin (1 month: + 1.09 ml/kg/min, 95% confidence interval [CI] 0.14-2.04; p = 0.021, and 3 months: + 1.06 ml/kg/min, 95% CI 0.07-2.04; p = 0.032). Similar positive findings were found when evaluating changes from baseline. No significant differences were observed in secondary endpoints. CONCLUSIONS: Among patients with stable HFrEF, dapagliflozin resulted in a significant improvement in peakVO(2) at 1 and 3 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04197635.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://incliva.portalinvestigacion.com/publicaciones/16599
url https://incliva.portalinvestigacion.com/publicaciones/16599
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv WILEY
publisher.none.fl_str_mv WILEY
dc.source.none.fl_str_mv EUROPEAN JOURNAL OF HEART FAILURE
ISSN: 13889842
ISSNe: 18790844
reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
instname:INCLIVA
instname_str INCLIVA
reponame_str r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
collection r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
repository.name.fl_str_mv
repository.mail.fl_str_mv
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