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Sodium Glucose Transporter Inhibitor

Empagliflozin 10 MG for Congenital Heart Disease (EmpaCHD Trial)

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline of kccq score at 1 year

Awards & highlights

EmpaCHD 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.Check my eligibility

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.See study design

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.

EmpaCHD Trial 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.

EmpaCHD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline of neuropsychological testing at 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline of neuropsychological testing at 1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline of neuropsychological testing at 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Ejection fraction (EF)

Change in Myocardial characteristics (Global strain on MRI)

Change in Myocardial characteristics (Global strain on echocardiogram)

+4 more

Secondary outcome measures

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%

Other

15%

Gastrointestinal

Worsening Heart Failure

Respiratory

Angioedema

Acute Kidney Injury

S. Aureus Bacteremia

Worsening Renal Function

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Empagliflozin

Placebo

EmpaCHD 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

~900

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Pittsburgh FoundationOTHER

5 Previous Clinical Trials

289 Total Patients Enrolled

Anita SarafLead Sponsor

Anita Saraf, MD, PhDPrincipal InvestigatorAssistant Professor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"As per clinicaltrials.gov, this particular investigation is not currently seeking volunteers. Initially shared on 2nd of January in 2024 and last revised on the 13th of February in the same year. While recruitment for this study has ceased, there are a substantial number of 1061 other ongoing trials actively enrolling participants."

Answered by AI

What are the potential risks associated with Empagliflozin 10 MG for individuals?

"According to our assessment at Power, the safety rating for Empagliflozin 10 MG is ranked as a 3 due to this study being in Phase 4, indicating regulatory approval."

Answered by AI

What is the primary objective of this research endeavor?

"The primary focus of this clinical investigation is to assess the change in functional exercise capacity among participants over a year, as measured by alterations from their baseline T1 mapping. Additional outcomes include variations in inflammatory serum biomarkers (specifically IL6, TNF-alpha, GDF-15, and IL10) quantified in pg/mL through ELISA assays by R&D systems to evaluate changes in the inflammatory response. Moreover, shifts in New york Heart Association (NYHA) Class will be recorded based on patients' subjective perception of their functional capability – NYHA Class I denotes no symptoms during both exercise and rest while NYHA Class IV indicates symptoms"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Anita Saraf 2024. "Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260059.

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