Impact of SGLT2 Inhibitors in Heart Transplant Recipients

NCT06147271 | Enrolling By Invitation Phase 2

• 1 other identifier: SGLT2i and heart transplant
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Transplant; Failure, Heart; Cardiac Allograft Vasculopathy; Rejection Heart Transplant

Keywords

heart transplantation; Cardiac Allograft Vasculopathy; Rejection

Outcome Measures

Primary Outcomes (1)

• Cardiac Allograft Vasculopathy

  Cardiac Allograft Vasculopathy

  6 to 8 months

Secondary Outcomes (4)

• cardiovascular death

  6 to 8 months

• all-cause mortality

  6 to 8 months

• cardiovascular hospitalization

  6 to 8 months

• worsening glomerular filtration rate

  6 to 8 months

Other Outcomes (7)

• fasting glucose

  6 to 8 months

• weight

  6 to 8 months

• blood pressure

  6 to 8 months

Study Arms (2)

intervention

ACTIVE COMPARATOR

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

Drug: SGLT2i

no intervention

NO INTERVENTION

All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to routine surveillance

Interventions

SGLT2i DRUG

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.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Ceara: lead
• Hospital de Messejana: collaborator

Study Sites (1)

Messejana Hospital

Fortaleza, Ceará, Brazil

Location

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jefferson Vieira, MD, MBA, PHD

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 27, 2023
• Study Start: November 20, 2023
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

BR (1)