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 groupsSponsors and collaborators
Anita Saraf
Lead sponsor
University of Pittsburgh
Sponsor institution
The Pittsburgh Foundation
Collaborator
Source ClinicalTrials.gov