Impact of SGLT2 Inhibitors in Heart Transplant Recipients

Phase 2

• Conditions: Rejection Heart Transplant; Transplant; Failure, Heart; Cardiac Allograft Vasculopathy
• Interventions: Drug: SGLT2i

• Registration Number: NCT06147271
• Lead Sponsor: Universidade Federal do Ceara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-19
• Study Start: 2023-11-20
• Study First Posted: 2023-11-27
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-02-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	SGLT2i	All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to SGLT2i intervention

Primary Outcome Measures

Name	Time	Method
Cardiac Allograft Vasculopathy	6 to 8 months	Cardiac Allograft Vasculopathy

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	6 to 8 months	all-cause mortality
cardiovascular hospitalization	6 to 8 months	cardiovascular hospitalization
cardiovascular death	6 to 8 months	cardiovascular death
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

Trial Locations

Locations (1)

Messejana Hospital; 🇧🇷 Fortaleza, Ceara, Brazil