Randomized Trial of SGLT2i in Heart Transplant Recipients

NCT06625073 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: NEPH-004-24S
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 6

Brief Summary

Heart transplant (HTx) is an established therapy for advanced heart disease that restores quality of life and improves survival. However, due to preexisting comorbidities combined with the immunosuppressive therapies required after transplantation, HTx recipients remain at high risk for kidney, cardiovascular (CV), and metabolic disease. Large randomized clinical trials have recently shown that sodium-glucose cotransporter 2 inhibitors (SGLT2i) have potent kidney protective and CV benefits in many populations of patients with chronic kidney disease (CKD), CV disease and/or diabetes. SGLT2i have not been studied prospectively in HTx recipients, which represents a barrier to their use in this population. In this multicenter randomized controlled trial in Veterans with HTx, investigators will evaluate the potential benefits of empagliflozin on kidney function, cardiometabolic risk, erythropoiesis, and functional status. A total of 200 Veterans will be randomly assigned to receive either empagliflozin 10 mg daily or a matching placebo for 12 months.

Conditions

Heart Transplant; Kidney Disease; Cardiovascular Disease

Keywords

Heart Transplant; Empagliflozin; Safety and Tolerability; Kidney Outcomes; Cardiometabolic Outcomes; Erythropoiesis; Functional Status; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Urinary albumin-to-creatinine ratio (UACR)

  UACR difference (mg/g) in subjects in active arm vs control arm

  12 months

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Adverse and serious adverse events difference in active arm vs control arm

  12 months

Secondary Outcomes (17)

• Estimated Glomerular Filtration Rate (eGFR)

  12 months

• Hemoglobin A1c (HbA1c)

  12 months

• Fasting blood glucose

  12 months

• Body weight

  12 months

• Systolic and diastolic blood pressure

  12 months

Study Arms (2)

Empagliflozin

EXPERIMENTAL

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Drug: Placebo

Interventions

Empagliflozin DRUG

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Also known as: Jardiance

Empagliflozin

Placebo DRUG

A starting dose of empagliflozin 10 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Participating subjects will remain at this dose for the whole study duration of 12 months.

Also known as: Control Group

Placebo

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Heart transplant recipient, 3 months after transplant

You may not qualify if:

• eGFR \<20 mL/min/1.73m2
• Type 1 diabetes mellitus
• HbA1C \>10%
• Baseline UACR \<30 mg/g in patients without T2D
• Known allergy or intolerance to SGLT2i
• Active uncontrolled infection
• Multiorgan transplant
• SGLT2i treatment in the last 30 days
• Pregnancy, breast-feeding or woman of child-bearing age not on birth control

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (6)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

NOT YET RECRUITING

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

NOT YET RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

NOT YET RECRUITING

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

RECRUITING

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

NOT YET RECRUITING

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705-2254, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Kidney Diseases

Interventions

empagliflozin; Control Groups

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Josef Stehlik, MD MPH

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Hanson, AAS BS

CONTACT

(801) 582-1565; Heather.Hanson@va.gov

Josef Stehlik, MD MPH

CONTACT

(801) 582-1565; josef.stehlik@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects will be randomized to either empagliflozin 10 mg daily for 12 months or matching placebo. The subjects and the investigators will not know whether subjects are randomized to active arm (empagliflozin) or to control arm (placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Empagliflozin 10 ng daily for 12 months

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 3, 2024
• Study Start: January 20, 2026
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)