Health TrialsbyHealthPanel

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

ConditionsAdult Congenital Heart DiseaseHeart Failure
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 10 MG

    Drug

    Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year

  • Placebo

    Drug

    To patients randomized to the placebo group, a placebo pill will be given

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Empagliflozin 10 MGExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Ejection fraction (EF)

Cardiac Magnetic Resonance Imaging (cMRI) and echocardiography will be used to measure ventricular function

Time frame
Change from baseline in ejection fraction at 1-year
2

Change in Myocardial characteristics (T1 mapping of cMRI)

Cardiac Magnetic Resonance Imaging (cMRI) without contrast will be used to measure myocardial characteristics

Time frame
Change from baseline in T1 mapping at 1-year
3

Change in Myocardial characteristics (Global strain on MRI)

Cardiac Magnetic Resonance Imaging (cMRI) will be used to measure myocardial characteristics

Time frame
Change from baseline of global strain on MRI at 1 year
4

Change in Myocardial characteristics (Global strain on echocardiogram)

Echocardiography will be used to measure myocardial characteristics such as global longitudinal strain

Time frame
Change from baseline of global strain on echocardiogram at 1 year

Secondary outcomes

1

Change in inflammatory serum biomarkers

Serum inflammatory markers will be measured using ELISA assays (R\&D systems) to test for change in inflammatory response. Biomarkers tested include IL6, TNF-alpha, GDF-15, and IL10. All biomarkers will be measured in pg/mL. All The biomarkers will be used predictively with clinical changes to assess correlation.

Time frame
Change from baseline of serum biomarkers at 1-year
2

Change in functional Neuropsychological Testing

NIH toolbox Cognitive battery (for ages 7-85) will be used to evaluate change in neuropsychological function. These tests include: Picture Vocabulary Test Oral Reading Recognition List Sorting Working Memory Test Pattern Comparison Processing Speed Test Picture Sequence Memory Test Flanker Inhibitory Control and Attention Test Dimensional Change Card Sort Test The Cognition Battery produces three composite scores. A score of 100 is average 1. Fluid Cognition Composite Score: A global assessment of individual and group fluid cognition functioning. 2. Crystallized Cognition Composite Score: A global assessment of individual and group verbal cognition. 3. Cognitive Function Composite Score: It provides a snapshot of general cognitive 15 functioning. (the above description of tests is directly extracted from https://www.nihtoolbox.org)

Time frame
Change from baseline of neuropsychological testing at 1-year
3

Change in New York Heart Association (NYHA) Class

Subjective perception of functional capacity with NYHA Class I patients reporting no symptoms with exercise and rest to NYHA Class IV patients reporting symptoms at rest.

Time frame
Change from baseline of NYHA Class at 1-year.
4

Change Patient-Reported Outcomes Measurement Information System (PROMIS)

PROMIS measures patient-reported outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. PROMIS scores have a mean of 50 and standard deviation (SD) of 10 in a referent population. Scores 0.5 - 1.0 SD worse than the mean = mild symptoms/impairment Scores 1.0 - 2.0 SD worse than the mean = moderate symptoms/impairment, Scores 2.0 SD or more worse than the mean = severe symptoms/impairment (information directly extracted from https://sphsoutcomes.net/promis-scoring)

Time frame
Change from baseline of PROMIS composite score at 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anita Saraf

Lead sponsor

University of Pittsburgh

Sponsor institution

The Pittsburgh Foundation

Collaborator

Source ClinicalTrials.gov
Apply now