Impact of SGLT2 Inhibitors in Heart Transplant Recipients

• Sponsor: Universidade Federal do Ceara (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06147271
• Collaborator: Hospital de Messejana (Other)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 20.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transplant; Failure, Heart; Cardiac Allograft Vasculopathy; Rejection Heart Transplant	Drug: SGLT2i	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Impact of SGLT2 Inhibitors on Cardioprotection in Patients Undergoing Heart Transplantation
• Anticipated Study Start Date: Nov 20, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intervention All adult patients undergoing a heart transplant between January 2017 and December 2023 at Hospital de Messejana randomized to SGLT2i 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.
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

Outcome Measures

Primary Outcome Measures

1. Cardiac Allograft Vasculopathy [6 to 8 months]

   Cardiac Allograft Vasculopathy

Secondary Outcome Measures

1. cardiovascular death [6 to 8 months]

   cardiovascular death

2. all-cause mortality [6 to 8 months]

   all-cause mortality

3. cardiovascular hospitalization [6 to 8 months]

   cardiovascular hospitalization

4. 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

Other Outcome Measures

1. fasting glucose [6 to 8 months]

   fasting glucose

2. weight [6 to 8 months]

   weight

3. blood pressure [6 to 8 months]

   blood pressure

4. Rejection [15 days post HTx]

   Rejection in a subgroup of early post-Htx patients

5. urinary tract infection [6 to 8 months]

   urinary tract infection

6. Hypovolemia [6 to 8 months]

   Hypovolemia

7. limb amputation [6 to 8 months]

   limb amputation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidade Federal do Ceara
• Hospital de Messejana

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jefferson Luis Vieira, Jefferson Vieira, MD, MBA, PHD, Universidade Federal do Ceara
• ClinicalTrials.gov Identifier: NCT06147271
• Other Study ID Numbers: SGLT2i and heart transplant
• First Posted: Nov 27, 2023
• Last Update Posted: Nov 27, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jefferson Luis Vieira, Jefferson Vieira, MD, MBA, PHD, Universidade Federal do Ceara: heart transplantation; Cardiac Allograft Vasculopathy; Rejection
• Additional relevant MeSH terms: Vascular Diseases

Study Results

No Results Posted as of Nov 27, 2023