DApagliflozin Cardiovascular Effects on Patients at End-stage REnal Disease
Status:
Not yet recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
Treatment with sodium glucose co-transporter type 2 inhibitors (Sglt2i) reduced the incidence
of cardiovascular death and hospitalization for heart failure by 29% in individuals with
moderate chronic kidney disease. Recent observations found that beyond its effect on
natriuresis, Sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial
function. This effect is not mitigated as glomerular filtration rate declines. Therefore,
plausibly treatment with Sglt2i may attenuate heart failure in individuals end-stage kidney
disease (ESKD) requiring dialysis, in whom cardiovascular disease remains the leading cause
of death. In this context, this project was designed to estimate the effect of dapagliflozin
on myocardial function of dialysis subjects. Individuals with diagnosed ESKD on dialysis for
at least 3 months, from both sexes, aged more than 18 years of age are eligible. Exclusion
criteria are pregnant woman, hepatic failure, and known allergy to study medications.
Eligible patients will be recruited from the Nephrology Division of the Clinics Hospital of
the University of Campinas (Unicamp). The study was designed as a prospective, randomized,
open-label, phase 4 clinical trial. Patients will be randomized, 1:1, for a 6-months
treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard
treatment alone (n=40). At the randomization visit, all patients will undergo a detailed
interview and medical examination by the physician-researcher, echocardiogram and blood
samples will be collected for further biochemical analysis and follow up visits will be
scheduled every month for endpoints disclosure and medications dispensation until the end of
study participation at the 6th month visit when echocardiogram and blood sample collection
will be repeated. Primary goal will be the difference between groups in mean change of
NTproBNP levels during treatment. Secondary endpoints will include mean change in ejection
fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass.