Transplant; Failure, Heart, Cardiac Allograft Vasculopathy, Rejection Heart Transplant
Conditions
Keywords
heart transplantation, Cardiac Allograft Vasculopathy, Rejection
Brief 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.
Interventions
DRUGSGLT2i
A randomized clinical trial of superiority with active control (2 arms), with central randomization to evaluate the efficacy and safety of adding dapagliflozin or empagliflozin 10 mg once daily to post-TxC routine compared with no intervention for 6-8 months.
Sponsors
Hospital de Messejana
Universidade Federal do Ceara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Patients who refuse to participate in the study, those with known hypersensitivity or intolerance to iSGLT2, individuals with type 1 diabetes mellitus, symptoms of hypotension, or systolic blood pressure below 80 mm Hg, an estimated glomerular filtration rate (eGFR) below 20 ml per minute per 1.73 m2 of body surface area, and pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Allograft Vasculopathy | 6 to 8 months | Cardiac Allograft Vasculopathy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| worsening glomerular filtration rate | 6 to 8 months | sustained ≥50% decline in eGFR, occurrence of end-stage kidney disease or death due to kidney disease |
| cardiovascular death | 6 to 8 months | cardiovascular death |
| all-cause mortality | 6 to 8 months | all-cause mortality |
| cardiovascular hospitalization | 6 to 8 months | cardiovascular hospitalization |
Other
| Measure | Time frame | Description |
|---|---|---|
| urinary tract infection | 6 to 8 months | urinary tract infection |
| Hypovolemia | 6 to 8 months | Hypovolemia |
| limb amputation | 6 to 8 months | limb amputation |
| fasting glucose | 6 to 8 months | fasting glucose |
| weight | 6 to 8 months | weight |
| blood pressure | 6 to 8 months | blood pressure |
| Rejection | 15 days post HTx | Rejection in a subgroup of early post-Htx patients |
Countries
Brazil
Outcome results
None listed