Impact of SGLT2 Inhibitors in Heart Transplant Recipients

Cardiac Allograft Vasculopathy Clinical Trial

Official title:

Impact of SGLT2 Inhibitors on Cardioprotection in Patients Undergoing Heart Transplantation

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06147271
• Other study ID #: SGLT2i and heart transplant
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: November 20, 2023
• Est. completion date: August 1, 2025

Study information

• Verified date: May 2024
• Source: Universidade Federal do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: August 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Allograft Vasculopathy
• Rejection Heart Transplant
• Transplant; Failure, Heart
• Vascular Diseases

Intervention

Drug:
• SGLT2i
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.

Locations

Country	Name	City	State
Brazil	Messejana Hospital	Fortaleza	Ceara

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Ceara	Hospital de Messejana

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fasting glucose	fasting glucose	6 to 8 months
Other	weight	weight	6 to 8 months
Other	blood pressure	blood pressure	6 to 8 months
Other	Rejection	Rejection in a subgroup of early post-Htx patients	15 days post HTx
Other	urinary tract infection	urinary tract infection	6 to 8 months
Other	Hypovolemia	Hypovolemia	6 to 8 months
Other	limb amputation	limb amputation	6 to 8 months
Primary	Cardiac Allograft Vasculopathy	Cardiac Allograft Vasculopathy	6 to 8 months
Secondary	cardiovascular death	cardiovascular death	6 to 8 months
Secondary	all-cause mortality	all-cause mortality	6 to 8 months
Secondary	cardiovascular hospitalization	cardiovascular hospitalization	6 to 8 months
Secondary	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