Impact of SGLT2 Inhibitors in Heart Transplant Recipients
Status:
Enrolling by invitation
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to test if SGLT2 inhibitors could prevent or delay the
development of Cardiac Allograft Vasculopathy (CAV) post-heart transplantation (TxC). The
main questions it aims to answer are:
Primary outcome: CAV, according to ISHLT grading system diagnosed by CCTA; Secondary
outcomes: cardiovascular death, all-cause mortality, hospitalization, worsening glomerular
filtration rate, fasting glucose, weight, and blood pressure.
Exploratory and safety outcomes: Rejection, hypoglycemia, urinary tract infection,
hypovolemia, and limb amputation.
HYPOTHESIS The null hypothesis is that SGLT2 inhibitors do not reduce the incidence of CAV in
transplanted patients.
The alternative hypothesis is that SGLT2 inhibitors reduce the incidence of CAV in
transplanted patients.METHODOLOGY Study Design A randomized clinical trial of superiority
with active control (2 arms), with central randomization and blinded evaluation of outcomes,
to evaluate the efficacy and safety of adding dapagliflozin or empagliflozin 10 mg once daily
to conventional post-TxC treatment compared with the treatment of isolated conventional
post-TxC for 6-8 months.
Study Sample Sample: All adult patients undergoing a heart transplant between January 2017
and December 2023 at Hospital de Messejana.
Inclusion Criteria Included: Patients of both sexes, aged ≥ 18 years, who have undergone
heart transplantation between January 2017 and December 2023 and are under the care of the
Heart Transplant and Heart Failure Unit at Hospital de Messejana.