Joaquim Barreto, Marilia Martins, Mauro Pascoa, Sheila T K Medorima, Isabella Bonilha, Daniel Campos Jesus, Cinthia E M Carbonara, Kelcia R S Quadros, Barbara Assato, Alessandra M Campos-Staffico, Gil Guerra Júnior, Wilson Nadruz, Rodrigo B de Oliveira, Andrei C Sposito
{"title":"达帕格列净对终末期肾病心血管的影响(DARE-ESKD-2)试验:原理与设计。","authors":"Joaquim Barreto, Marilia Martins, Mauro Pascoa, Sheila T K Medorima, Isabella Bonilha, Daniel Campos Jesus, Cinthia E M Carbonara, Kelcia R S Quadros, Barbara Assato, Alessandra M Campos-Staffico, Gil Guerra Júnior, Wilson Nadruz, Rodrigo B de Oliveira, Andrei C Sposito","doi":"10.1080/14740338.2024.2412228","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Dapagliflozin prevents myocardial dysfunction in chronic kidney disease patients regardless of residual kidney function. We hypothesized that this effect is extensible also to patients on dialysis.</p><p><strong>Research design and methods: </strong>The DARE-ESKD-2 is an ongoing, single-center, open-label randomized clinical trial designed to determine the effects of adding dapagliflozin to standard treatment on myocardial function and structure. Eligible patients were adults on a regular dialysis scheme for more than 3 months. Pregnancy, liver failure, allergy to the investigational drug, and prior use of SGLT2i were exclusion criteria. Participants were randomized in a 1:1 ratio to dapagliflozin or standard treatment groups for 24-weeks. The primary goal is to compare the change in NT-proBNP levels between study arms, and secondary goals include comparing the between-group difference in left ventricle global longitudinal strain, indexed mass, ejection fraction, and E/e` ratio, and on symptoms scale and 6-minute walk test distance. An exploratory analysis will evaluate changes in body composition and bone densitometry.</p><p><strong>Results: </strong>The trial has finished the enrollment of 80 patients, who are currently being followed-up.</p><p><strong>Conclusions: </strong>This trial will provide novel data on myocardial effects of SGLT2i in dialysis recipients. Results from this study may provide evidence to support SGLT2i use in ESKD.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-7"},"PeriodicalIF":3.0000,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.\",\"authors\":\"Joaquim Barreto, Marilia Martins, Mauro Pascoa, Sheila T K Medorima, Isabella Bonilha, Daniel Campos Jesus, Cinthia E M Carbonara, Kelcia R S Quadros, Barbara Assato, Alessandra M Campos-Staffico, Gil Guerra Júnior, Wilson Nadruz, Rodrigo B de Oliveira, Andrei C Sposito\",\"doi\":\"10.1080/14740338.2024.2412228\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Dapagliflozin prevents myocardial dysfunction in chronic kidney disease patients regardless of residual kidney function. 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Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.
Background: Dapagliflozin prevents myocardial dysfunction in chronic kidney disease patients regardless of residual kidney function. We hypothesized that this effect is extensible also to patients on dialysis.
Research design and methods: The DARE-ESKD-2 is an ongoing, single-center, open-label randomized clinical trial designed to determine the effects of adding dapagliflozin to standard treatment on myocardial function and structure. Eligible patients were adults on a regular dialysis scheme for more than 3 months. Pregnancy, liver failure, allergy to the investigational drug, and prior use of SGLT2i were exclusion criteria. Participants were randomized in a 1:1 ratio to dapagliflozin or standard treatment groups for 24-weeks. The primary goal is to compare the change in NT-proBNP levels between study arms, and secondary goals include comparing the between-group difference in left ventricle global longitudinal strain, indexed mass, ejection fraction, and E/e` ratio, and on symptoms scale and 6-minute walk test distance. An exploratory analysis will evaluate changes in body composition and bone densitometry.
Results: The trial has finished the enrollment of 80 patients, who are currently being followed-up.
Conclusions: This trial will provide novel data on myocardial effects of SGLT2i in dialysis recipients. Results from this study may provide evidence to support SGLT2i use in ESKD.
期刊介绍:
Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports.
Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.