Impact of SGLT2 Inhibitors in Heart Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of SGLT2 Inhibitors on Cardioprotection in Patients Undergoing Heart Transplantation

Conditions
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Transplant; Failure, Heart, Cardiac Allograft Vasculopathy, Rejection Heart Transplant

Intervention / Treatment
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* Drug: SGLT2i


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intervention<br>All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to SGLT2i intervention | Drug: SGLT2i<br>* 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.<br>|
| No Intervention: no intervention<br>All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to routine surveillance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Allograft Vasculopathy | Cardiac Allograft Vasculopathy | 6 to 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death | cardiovascular death | 6 to 8 months | 
| all-cause mortality | all-cause mortality | 6 to 8 months | 
| cardiovascular hospitalization | cardiovascular hospitalization | 6 to 8 months | 
| worsening glomerular filtration rate | sustained ≥50% decline in eGFR, occurrence of end-stage kidney disease or death due to kidney disease | 6 to 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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heart transplantation, Cardiac Allograft Vasculopathy, Rejection