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Sodium Glucose Transporter Inhibitor

Empagliflozin for Congenital Heart Disease (EmpaCHD Trial)

Phase 4
Recruiting
Led By Anita Saraf, MD, PhD
Research Sponsored by Anita Saraf
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnoses of Congenital Heart Disease
ACHD level of structural complexity II or III
Must not have
Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022)
Diagnosed with Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline of kccq score at 1 year
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

"This trial aims to see if a new drug called Empagliflozin (Jardiance) can help adult patients with congenital heart disease. The goal is to determine if this drug is

Who is the study for?
Adults with congenital heart disease who may be experiencing heart failure can join this trial. Specific details about eligibility are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.
What is being tested?
The trial is testing Empagliflozin (Jardiance), a medication for heart failure, against a placebo in adults with congenital heart defects. The aim is to see if it's effective and safe for these patients.
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration, low blood sugar levels (in people taking insulin or insulin secretagogues), yeast infections, and possibly lower limb amputation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a heart condition present since birth.
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My heart condition is moderately to highly complex.
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My heart's pumping ability has dropped by more than 5% in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot take Jardiance/Entresto or certain heart failure medications due to adverse reactions.
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I have been diagnosed with diabetes.
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I have taken Jardiance within the last 4 weeks.
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I have a history of liver disease.
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I have a genetic disorder affecting my body's metabolism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline of serum biomarkers at 1-year
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline of serum biomarkers at 1-year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Ejection fraction (EF)
Change in Myocardial characteristics (Global strain on MRI)
Change in Myocardial characteristics (Global strain on echocardiogram)
+4 more
Secondary study objectives
Change Patient-Reported Outcomes Measurement Information System (PROMIS)
Change in Kansas City Cardiomyopathy (KCCQ)
Change in Neuro-QOL
+3 more

Side effects data

From 2019 Phase 2 trial • 80 Patients • NCT03200860
38%
Renal/Urinary
33%
Musculoskeletal
23%
Cardiovascular
23%
Metabolic
15%
Gastrointestinal
15%
Other
8%
Worsening Heart Failure
8%
Respiratory
3%
Worsening Renal Function
3%
S. Aureus Bacteremia
3%
Angioedema
3%
Acute Kidney Injury
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Empagliflozin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin 10 MGExperimental Treatment1 Intervention
Empagliflozin 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.
Group II: PlaceboPlacebo Group1 Intervention
Placebo for 1 year
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 10 MG
2016
Completed Phase 4
~990

Find a Location

Who is running the clinical trial?

Anita SarafLead Sponsor
The Pittsburgh FoundationOTHER
6 Previous Clinical Trials
349 Total Patients Enrolled
1 Trials studying Heart Failure
30 Patients Enrolled for Heart Failure
Anita Saraf, MD, PhDPrincipal InvestigatorAssistant Professor
~27 spots leftby Dec 2026
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