Dapagliflozin cardiovascular effects on end-stage kidney disease (DARE-ESKD-2) trial: rationale and design.

Autor:	Barreto J; UNICAMP: Universidade Estadual de Campinas., Martins M; UNICAMP: Universidade Estadual de Campinas., Pascoa M; UNICAMP: Universidade Estadual de Campinas., Medorima STK; UNICAMP: Universidade Estadual de Campinas., Bonilha I; UNICAMP: Universidade Estadual de Campinas., Jesus DC; UNICAMP: Universidade Estadual de Campinas., Carbonara CEM; UNICAMP: Universidade Estadual de Campinas., Quadros KRS; UNICAMP: Universidade Estadual de Campinas., Assato B; UNICAMP: Universidade Estadual de Campinas., Campos-Staffico AM; Creighton University., Júnior GG; UNICAMP: Universidade Estadual de Campinas., Nadruz W; UNICAMP: Universidade Estadual de Campinas., de Oliveira RB; UNICAMP: Universidade Estadual de Campinas., Sposito AC; UNICAMP: Universidade Estadual de Campinas.
Jazyk:	angličtina
Zdroj:	Research square [Res Sq] 2023 Oct 19. Date of Electronic Publication: 2023 Oct 19.
DOI:	10.21203/rs.3.rs-3434207/v1
Abstrakt:	Purpose: Sodium glucose co-transporter 2 inhibitors (SGLT2i) remarkably reduced the incidence of hospitalization for heart failure and cardiovascular death of conservatively managed chronic kidney disease. We hypothesized that adding SGLT2i to standard treatment would yield cardiovascular benefits also in end-stage kidney disease (ESKD) individuals on dialysis. Methods: The DARE-ESKD-2 Trial (NCT05685394) is an ongoing, single-center, open-label, controlled trial aimed at assessing the cardiovascular effects of dapagliflozin in ESKD on dialysis. Eligible patients are adults on renal replacement therapy for more than 3 prior to enrollment. Exclusion criteria encompass pregnancy, liver failure, and current use of a SGLT2i. After signing an informed consent form, participants are randomized 1:1 to either dapagliflozin 10mg PO plus standard treatment or standard treatment alone for 6 months. Echocardiogram, anthropometry, blood sample collection, 6-min walk test, gait speed, and Kansas City Cardiomyopathy Questionnaire (KCCQ), are performed at baseline and at study termination. Participants are contacted monthly during treatment for outcomes disclosure. The primary endpoint of our study is the between-groups differences in posttreatment changes in plasma levels of N-terminal pro-B natriuretic peptide. Secondary endpoints include the differences between groups in the changes of echocardiography measurements, cardiopulmonary tests performance, body composition. The incidence of safety endpoints will also be diligently compared between study arms. Conclusion: The DARE-ESKD-2 trial will provide unprecedented data on the cardiovascular safety and efficacy of SGLT2i in ESKD individuals on dialysis. This study will pave the grounds for improving clinical outcomes of dialysis recipients. Competing Interests: Declaration of Competing Interest Authors declare that they have no competing interest in this manuscript.
Databáze:	MEDLINE
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