Clinical trial NCT06147271: Impact of SGLT2 Inhibitors in Heart Transplant Recipients
Official title: Impact of SGLT2 Inhibitors on Cardioprotection in Patients Undergoing Heart Transplantation
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Transplant; Failure, Heart
Cardiac Allograft Vasculopathy
Rejection Heart Transplant
Keywords: heart transplantation
Cardiac Allograft Vasculopathy
Rejection
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
Collaborators: name: Hospital de Messejana
First posted: 2023-11-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Allograft Vasculopathy
timeFrame: 6 to 8 months
Secondary outcomes:
measure: cardiovascular death
timeFrame: 6 to 8 months
measure: all-cause mortality
timeFrame: 6 to 8 months
measure: cardiovascular hospitalization
timeFrame: 6 to 8 months
measure: worsening glomerular filtration rate
timeFrame: 6 to 8 months
Other outcomes:
measure: fasting glucose
timeFrame: 6 to 8 months
measure: weight
timeFrame: 6 to 8 months
measure: blood pressure
timeFrame: 6 to 8 months
measure: Rejection
timeFrame: 15 days post HTx
measure: urinary tract infection
timeFrame: 6 to 8 months
measure: Hypovolemia
timeFrame: 6 to 8 months
measure: limb amputation
timeFrame: 6 to 8 months
Locations:
city: Fortaleza
country: Brazil
facility: Messejana Hospital
state: Ceara
Study officials:
References: