Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147271
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-07
First Post:
2023-11-19
Brief Title:
Impact of SGLT2 Inhibitors in Heart Transplant Recipients
Sponsor:
Universidade Federal do Ceara
Organization:
Universidade Federal do Ceara
Study Overview
Official Title:
Impact of SGLT2 Inhibitors on Cardioprotection in Patients Undergoing Heart Transplantation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsMETHODOLOGY 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
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 patientsMETHODOLOGY 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None