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SGLT-2 Inhibitor

Empagliflozin for Heart Failure

Phase 3
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will help researchers understand how a new diabetes drug can help people with heart failure. The study will look at how well the drug works and what side effects it may have.

Who is the study for?
Adults aged 50-85 with clinical heart failure and a preserved ejection fraction (EF) over 50% can join this trial. It's not for those who've had bad reactions to SGLT-2 inhibitors, are already on such treatments, have severe kidney issues, unstable heart artery disease, serious irregular heartbeat problems, extreme obesity or can't exercise.Check my eligibility
What is being tested?
The study is testing the effects of Empagliflozin on people with heart failure who still have good pumping function. Participants will take the drug daily for 12 weeks and undergo tests to see if it improves their fitness level and lowers pressure in the blood vessels of their lungs during exercise.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (a serious condition related to diabetes), genital yeast infections in women and men, increased cholesterol levels, joint pain and allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Oxygen Uptake
Peak Pulmonary Capillary Wedge Pressure (PCWP)
Secondary outcome measures
6 minute walk time
Cardiac Output at Rest and During Exercise
Diastolic parameters at rest and during submaximal exercise
+6 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
8%
Worsening Heart Failure
8%
Respiratory
3%
Angioedema
3%
Acute Kidney Injury
3%
S. Aureus Bacteremia
3%
Worsening Renal Function
3%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
This arm of the study will take 10 mg empagliflozin daily for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,791 Total Patients Enrolled
23 Trials studying Heart Failure
13,331 Patients Enrolled for Heart Failure
Boehringer IngelheimIndustry Sponsor
2,505 Previous Clinical Trials
11,340,284 Total Patients Enrolled
25 Trials studying Heart Failure
120,120 Patients Enrolled for Heart Failure

Media Library

Empagliflozin (SGLT-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05139472 — Phase 3
Heart Failure Research Study Groups: Treatment Arm
Heart Failure Clinical Trial 2023: Empagliflozin Highlights & Side Effects. Trial Name: NCT05139472 — Phase 3
Empagliflozin (SGLT-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139472 — Phase 3

Frequently Asked Questions

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

To your knowledge, is this the first time this type of treatment has been tested?

"Currently, there are 50 Empagliflozin 10 MG clinical trials underway in 237 cities and 43 countries. The first study began in 2018 and completed its Phase 3 stage that year. 175 people participated in the trial, which was sponsored by Boehringer Ingelheim."

Answered by AI

What are the risks associated with Empagliflozin 10 MG?

"Empagliflozin 10 MG has received a safety rating of 3."

Answered by AI

Are enrolling in this clinical trial?

"That is correct. The study is still ongoing and actively recruiting patients, as shown by the clinicaltrials.gov website. The trial was created on 11/9/2021 and updated on 7/20/2022. They are looking for 8 more patients at 2 locations."

Answered by AI

Are there other instances where Empagliflozin 10 MG has been tested in a clinical setting?

"There are currently 50 ongoing studies evaluating the efficacy of Empagliflozin 10 MG. Of these, 13 are in Phase 3. Münster, Maryland is where the majority of these trials are taking place, but there are 1008 locations worldwide conducting these studies."

Answered by AI

Is this trial accessible to adults over the age of 18?

"According to the parameters set out by the researchers, only patients aged 50 to 85 can enroll in this trial. However, there are 212 other clinical trials for patients under 18 and 1675 trials for patients over the age of 65."

Answered by AI

What is Empagliflozin 10 MG's purpose?

"Empagliflozin 10 MG is most frequently used to mitigate cardiovascular diseases. That said, this medication can also be used to improve outcomes for heart failure, type 2 diabetes mellitus, and cardiovascular mortality."

Answered by AI

Which patients would be an ideal match for this clinical trial?

"This experiment can take up to 8 individuals that are between 50 and 85 years old who have heart failure, diastolic. To be eligible, potential patients must also meet the following: they must be adults ages 50-85, have clinical heart failure, and an ejection fraction > 50%."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction
James MacNamara 2021. "Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139472.
~2 spots leftby Apr 2025
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