Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnita Saraf
About this trial
The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).
Eligibility criteria
Qualifiers
Diagnoses of Congenital Heart Disease
Age 18+
ACHD level of structural complexity II or III
Recent (<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF < 60%
Disqualifiers
Diagnosed with Diabetes
Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022).
Previous therapy with Jardiance at <4 weeks
Glomerular Filtration Rate <20
Trial design
Treatments tested in this trial
- Empagliflozin 10 MG
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsLocations
3Children's Hospital of Pittsburgh15224, PittsburghPennsylvania, United States
Magee Women's Hospital15213, PittsburghPennsylvania, United States
Presbyterian Hospital15213, PittsburghPennsylvania, United States
Sponsors and collaborators
Anita Saraf
Lead sponsor
University of Pittsburgh
Sponsor institution
The Pittsburgh Foundation
Collaborator
Source ClinicalTrials.gov