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Empagliflozin Group for Heart Failure

Q: Are there any vacancies available for patients to participate in this trial?

<p>According to the information available on clinicaltrials.gov, this specific trial is not currently actively recruiting participants. Its initial posting was on March 1st, 2024 and it was last updated on January 18th, 2024. However, it's worth noting that there are currently a total of 774 other ongoing clinical trials seeking eligible candidates for enrollment.</p>

Q: Are individuals above the age of 65 eligible to participate in this clinical trial?

<p>For individuals interested in participating in this clinical trial, the minimum age requirement is 18 years old while the upper age limit stands at 70.</p>

Phase < 1

Recruiting

Led By Ralph DeFronzo, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80 years

Type 2 Diabetes Mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months

Awards & highlights

Study Summary

This trial will look at how a certain type of medication affects people with type 2 diabetes and heart failure. The medication may provide extra fuel for the heart and improve its function. The researchers will measure

Who is the study for?

This trial is for high-risk individuals with type 2 diabetes and heart failure who have a reduced ability of the heart to pump blood (HFrEF). Participants should not be currently using SGLT2 inhibitors or medications affecting ketone levels.Check my eligibility

What is being tested?

The study is testing if Acipimox, Empagliflozin, or a placebo can improve heart function by increasing ketone levels in the blood. The effects on the left ventricle's pumping ability are measured.See study design

What are the potential side effects?

Possible side effects include low blood sugar, dehydration, urinary tract infections from Empagliflozin; flushing and gastrointestinal discomfort from Acipimox; and no expected active side effects from the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Select...

I have Type 2 Diabetes.

Select...

I have moderate to severe heart failure with an ejection fraction below 50%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

ATPmax production

Change in Adenosine Triphosphate (ATP)

Change in Inorganic Phosphate

+2 more

Secondary outcome measures

6-min walking test

Acetoacetate concentrations

Patient-Reported Outcomes Measure Information System

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Empagliflozin GroupExperimental Treatment2 Interventions

Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months

Group II: Placebo groupPlacebo Group2 Interventions

Subjects will be randomized to receive the empagliflozin placebo for 3 months

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,359 Total Patients Enrolled

5 Trials studying Heart Failure

234 Patients Enrolled for Heart Failure

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,521 Total Patients Enrolled

6 Trials studying Heart Failure

357 Patients Enrolled for Heart Failure

Ralph DeFronzo, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

11 Previous Clinical Trials

1,043 Total Patients Enrolled

2 Trials studying Heart Failure

108 Patients Enrolled for Heart Failure

Frequently Asked Questions

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

Are there any vacancies available for patients to participate in this trial?

"According to the information available on clinicaltrials.gov, this specific trial is not currently actively recruiting participants. Its initial posting was on March 1st, 2024 and it was last updated on January 18th, 2024. However, it's worth noting that there are currently a total of 774 other ongoing clinical trials seeking eligible candidates for enrollment."

Answered by AI

Are individuals above the age of 65 eligible to participate in this clinical trial?

"For individuals interested in participating in this clinical trial, the minimum age requirement is 18 years old while the upper age limit stands at 70."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketones, SGLT2, HFrEF

2024. "Ketones, SGLT2, HFrEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229678.

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