A Phase 2 interventional study of SGLT2i in Transplant; Failure, Heart, Cardiac Allograft Vasculopathy and Rejection Heart Transplant, sponsored by Universidade Federal do Ceara. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Universidade Federal do Ceara · Phase 2, Interventional, and Prevention
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.
56 studies on the registry are indexed under Rejection, Psychology; 29 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 27 interventional studies indexed under Rejection, Psychology.
Browse Rejection, Psychology studies →Universidade Federal do Ceara is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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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
All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to SGLT2i intervention
Drug: SGLT2i
All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to routine surveillance
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.
Cardiac Allograft Vasculopathy
Cardiac Allograft Vasculopathy
Time frame: 6 to 8 months
cardiovascular death
cardiovascular death
Time frame: 6 to 8 months
all-cause mortality
all-cause mortality
Time frame: 6 to 8 months
cardiovascular hospitalization
cardiovascular hospitalization
Time frame: 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
Time frame: 6 to 8 months
fasting glucose
fasting glucose
Time frame: 6 to 8 months
weight
weight
Time frame: 6 to 8 months
blood pressure
blood pressure
Time frame: 6 to 8 months
Rejection
Rejection in a subgroup of early post-Htx patients
Time frame: 15 days post HTx
urinary tract infection
urinary tract infection
Time frame: 6 to 8 months
Hypovolemia
Hypovolemia
Time frame: 6 to 8 months
limb amputation
limb amputation
Time frame: 6 to 8 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Feb 2025, 14 months after the start.
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This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium-Glucose Transporter 2 Inhibitors
Universidade Federal do Ceara