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Adult Congenital Heart DiseasePhase 4EmpaCHDNCT06260059

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

A Phase 4 study testing Empagliflozin 10 MG in people with Adult Congenital Heart Disease and Heart Failure, run by Anita Saraf at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Congenital Heart Disease, Heart Failure
What is being tested?
Empagliflozin 10 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
3 sitesUnited States
Study dates
17 Sep 2024to 1 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%
  • Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by > 5% in the last 6 months or less.
  • Must be able to complete neurocognitive assessments on a handheld computer.

Who cannot join

  • 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
  • Pregnancy, breastfeeding, or planning to become pregnant in the coming year
  • History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis
Show all 14Show fewer
  • History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1)
  • Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,
  • Gaucher disease,
  • Tay-Sachs disease,
  • Mucolipidosis IV,
  • Niemann-Pick disease,
  • Type A mitochondrial disease,
  • Metabolic disorders related to glucose metabolism

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease

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).

Read the detailed description

As CHD adolescents transition to adulthood, it is becoming evident that in addition to their structural cardiac abnormalities, they also have an intrinsic disease of the heart muscle which manifests as abnormal heart rhythm (arrhythmia) and decreased function (heart failure).

The lifesaving cardiac surgeries during childhood can also contribute to this dysfunction (cardiomyopathy). Hence, patients with CHD require multiple interventions and close clinical follow-up throughout their life. Currently, there are over 2.5 million CHD patients in the U.S. alone, and an additional 40,000 babies are born with CHD every year. Up to 50% of these patients require inpatient hospital care at some point due to their cardiomyopathy.

High-risk ACHD patients do not receive treatment until they present with heart failure or arrhythmia, at which time there is significant evidence of myocardial disease and dysfunction.

Empagliflozin (Jardiance) is an FDA-approved drug that significantly reduces hospitalization risk and cardiovascular death in adult patients with non-CHD heart failure. Studies show that Empagliflozin protects the heart from inflammation, and preliminary evaluation of Empagliflozin in symptomatic ACHD patients showed improved cardiac function and a reduction in heart failure including decreased shortness of breath and increased functional capacity. Empagliflozin as a preventative therapy may delay the onset of comorbidities by reducing inflammation in ACHD patients.

The study hypothesis is that the administration of once-a-day oral Jardiance (Empagliflozin) medication for one year reduces arrhythmia and cardiomyopathy and lowers serum circulating inflammatory factors and improves neurocognitive outcomes in susceptible ACHD patients.

  1. Does Empagliflozin 10 milligrams (MG) improve cardiac function in ACHD patients
  2. Does Empagliflozin 10 milligrams (MG) improve functional status in ACHD patients
Being tested
Empagliflozin 10 MG, Placebo
Keywords
congenital heart disease, reduced exercise capacity, decreased cardiac function
Medical subject headings
Heart Defects, Congenital, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 MGDrug

    Also called Jardiance, Empagliflozin

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

  • PlaceboDrug

    Also called Placebo Drug

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

Study groups in NCT06260059
Study groupRoleWhat they receive
Empagliflozin 10 MGExperimentalEmpagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.
Receives: Drug: Empagliflozin 10 MG
PlaceboPlacebo comparatorPlacebo for 1 year
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ejection fraction (EF)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Change from baseline of global strain on echocardiogram at 1 year

  5. Change in functional exercise capacity of participants.

    Cardiopulmonary exercise stress testing (CPET) will be used to measure functional change in MVO2, RER, Exercise time, METs, and vitals.

    Measured: Change from baseline of exercise capacity at 1-year

  6. Number of Participants Hospitalized for Cardiac Reasons or heart transplantation

    Hospitalization for cardiac reasons or heart transplantation

    Measured: Cardiac hospitalizations or transplantation at 1 year.

  7. Number of Deaths

    Number of patients who died during the study from all causes

    Measured: Number of deaths at 1 year

Secondary outcomes (6)

  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.

    Measured: 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)

    Measured: 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.

    Measured: 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)

    Measured: Change from baseline of PROMIS composite score at 1 year

  5. Change in Kansas City Cardiomyopathy (KCCQ)

    The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.

    (Extracted from https://www.ncbi.nlm.nih.gov)

    Measured: Change from baseline of KCCQ score at 1 year

  6. Change in Neuro-QOL

    Neuro-QoL measures quantify the physical, mental, and social effects experienced by adults and children living with neurological conditions. Function scales, the range of responses is 0 to 4, with 0 being the worst possible total score and 80 being the best.

    Measured: Change from baseline of Neuro-QOL score at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2024
  2. Study start17 Sep 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group 1: Empagliflozin 10 MG daily Group 2: Placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260059
Sponsor's protocol ID
STUDY23070148
Other IDs
Pitt2024
Acronym
EmpaCHD
Status last verified
Sep 2026
First submitted
2 Jan 2024
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Plan to not share individual participant data

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin 10 MG in people with Adult Congenital Heart Disease and Heart Failure, run by Anita Saraf at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ejection fraction (EF) (time frame: Change from baseline in ejection fraction at 1-year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06260059.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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