Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial.
AIMS: Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospi...
| Autores: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2022 |
| País: | España |
| Institución: | INCLIVA |
| Repositorio: | r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
| OAI Identifier: | oai:incliva.fundanetsuite.com:p16090 |
| Acceso en línea: | https://incliva.portalinvestigacion.com/publicaciones/16090 |
| Access Level: | acceso abierto |
| Palabra clave: | Dapagliflozin Heart failure Sodium-glucose co-transporter 2 inhibitor Trial design |
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Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial.Amat-Santos, Ignacio JSanchez-Luna, Juan PAbu-Assi, EmadMelendo Viu, MariaCruz-Gonzalez, IgnacioNombela-Franco, LuisMunoz Garcia, Antonio JesusGarcia Blas, Sergiode la Torre Hernandez, Jose MariaRomaguera, RafaelSanchez-Recalde, AngelDiez Gil, Jose LuisLopez Otero, DiegoGheorge, LiviaIbanez, BorjaIniguez Romo, AndresRaposeiras-Roubin, SergioDapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI)Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) InvestigaDapagliflozinHeart failureSodium-glucose co-transporter 2 inhibitorTrial designAIMS: Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus, reduced left ventricular ejection fraction and chronic kidney disease. However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. METHODS: DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicentre trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing TAVI. Candidate patients should have prior history of HF admission plus =1 of the following criteria: (i) diabetes mellitus, (ii) left ventricular ejection fraction =40%, or (iii) estimated glomerular filtration rate between 25 and 75 ml/min/1.73 m(2) . A total of 1020 patients will be randomized (1:1) to dapagliflozin vs. no dapagliflozin. Key secondary outcomes include: (i) incidence rate of individual components of the primary outcome; (ii) cardiovascular mortality; (iii) the composite of HF hospitalization or cardiovascular death; and (iv) total number of HF rehospitalizations. CONCLUSION: DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI.WILEY2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://incliva.portalinvestigacion.com/publicaciones/16090EUROPEAN JOURNAL OF HEART FAILUREISSN: 13889842ISSNe: 18790844reponame:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVAinstname:INCLIVAInglésinfo:eu-repo/semantics/openAccessoai:incliva.fundanetsuite.com:p160902026-06-07T16:35:31Z |
| dc.title.none.fl_str_mv |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| title |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| spellingShingle |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. Amat-Santos, Ignacio J Dapagliflozin Heart failure Sodium-glucose co-transporter 2 inhibitor Trial design |
| title_short |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| title_full |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| title_fullStr |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| title_full_unstemmed |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| title_sort |
Rationale and design of the Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) randomized trial. |
| dc.creator.none.fl_str_mv |
Amat-Santos, Ignacio J Sanchez-Luna, Juan P Abu-Assi, Emad Melendo Viu, Maria Cruz-Gonzalez, Ignacio Nombela-Franco, Luis Munoz Garcia, Antonio Jesus Garcia Blas, Sergio de la Torre Hernandez, Jose Maria Romaguera, Rafael Sanchez-Recalde, Angel Diez Gil, Jose Luis Lopez Otero, Diego Gheorge, Livia Ibanez, Borja Iniguez Romo, Andres Raposeiras-Roubin, Sergio Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investiga |
| author |
Amat-Santos, Ignacio J |
| author_facet |
Amat-Santos, Ignacio J Sanchez-Luna, Juan P Abu-Assi, Emad Melendo Viu, Maria Cruz-Gonzalez, Ignacio Nombela-Franco, Luis Munoz Garcia, Antonio Jesus Garcia Blas, Sergio de la Torre Hernandez, Jose Maria Romaguera, Rafael Sanchez-Recalde, Angel Diez Gil, Jose Luis Lopez Otero, Diego Gheorge, Livia Ibanez, Borja Iniguez Romo, Andres Raposeiras-Roubin, Sergio Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investiga |
| author_role |
author |
| author2 |
Sanchez-Luna, Juan P Abu-Assi, Emad Melendo Viu, Maria Cruz-Gonzalez, Ignacio Nombela-Franco, Luis Munoz Garcia, Antonio Jesus Garcia Blas, Sergio de la Torre Hernandez, Jose Maria Romaguera, Rafael Sanchez-Recalde, Angel Diez Gil, Jose Luis Lopez Otero, Diego Gheorge, Livia Ibanez, Borja Iniguez Romo, Andres Raposeiras-Roubin, Sergio Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) Investiga |
| author2_role |
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 Sodium-glucose co-transporter 2 inhibitor Trial design |
| topic |
Dapagliflozin Heart failure Sodium-glucose co-transporter 2 inhibitor Trial design |
| description |
AIMS: Despite aortic stenosis (AS) relief, patients undergoing transcatheter aortic valve implantation (TAVI) are at increased risk of developing heart failure (HF) within first months of intervention. Sodium-glucose co-transporter 2 (SGLT-2) inhibitors have been shown to reduce the risk of HF hospitalization in individuals with diabetes mellitus, reduced left ventricular ejection fraction and chronic kidney disease. However, the effect of SGLT-2 inhibitors on outcomes after TAVI is unknown. The Dapagliflozin after Transcatheter Aortic Valve Implantation (DapaTAVI) trial is designed to assess the clinical benefit and safety of the SGLT-2 inhibitor dapagliflozin in patients undergoing TAVI. METHODS: DapaTAVI is an independent pragmatic, controlled, prospective, randomized, open-label blinded endpoint, multicentre trial conducted in Spain, evaluating the effect of dapagliflozin 10 mg/day on the risk of death and worsening HF in patients with severe AS undergoing TAVI. Candidate patients should have prior history of HF admission plus =1 of the following criteria: (i) diabetes mellitus, (ii) left ventricular ejection fraction =40%, or (iii) estimated glomerular filtration rate between 25 and 75 ml/min/1.73 m(2) . A total of 1020 patients will be randomized (1:1) to dapagliflozin vs. no dapagliflozin. Key secondary outcomes include: (i) incidence rate of individual components of the primary outcome; (ii) cardiovascular mortality; (iii) the composite of HF hospitalization or cardiovascular death; and (iv) total number of HF rehospitalizations. CONCLUSION: DapaTAVI will determine the efficacy and safety of dapagliflozin in a broad spectrum of frail patients after AS relief by TAVI. |
| 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/16090 |
| url |
https://incliva.portalinvestigacion.com/publicaciones/16090 |
| 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 |
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INCLIVA |
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r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
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r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA |
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