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SGLT2 Inhibitor

SGLT2 Inhibitors for Heart Failure

Phase < 1
Recruiting
Led By Carolina Solis-Herrera, 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
Stable dose of guideline-directed medications for heart failure
Age 18-80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights

Study Summary

This trial will study the effects of SGLT2i drugs (which cause increased ketone levels in the blood) on various measures of health, including muscle and heart function, exercise capacity, and quality of life.

Who is the study for?
This trial is for adults aged 18-80 with Type 2 Diabetes and moderate heart failure (NYHA Class II-III) who have a reduced heart function (EF <50%). They should have a stable weight, controlled blood pressure, and not be on certain diabetes or heart failure medications. People with very high resting heart rates, extreme hypertension, low oxygen levels at rest, or physical disabilities that prevent exercise are excluded.Check my eligibility
What is being tested?
The study is testing the effects of Empagliflozin (a drug for diabetes that also affects fat metabolism) against a placebo in improving muscle energy use, exercise capacity, and patient-reported outcomes in those with both Type 2 Diabetes and heart failure.See study design
What are the potential side effects?
Empagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, ketoacidosis (high acid levels in the blood), genital yeast infections in females and males. It can also affect kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart failure medication dose has been stable.
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I am between 18 and 80 years old.
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I have moderate to severe heart failure with an ejection fraction below 50%.
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I have Type 2 Diabetes.

Timeline

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 minute walk test
Acetoacetate concentrations
Cardiopulmonary Function
+2 more

Side effects data

From 2023 Phase 1 & 2 trial • 29 Patients • NCT04907214
17%
Skin infection
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Empagliflozin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin GroupExperimental Treatment1 Intervention
Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
Group II: Placebo groupPlacebo Group1 Intervention
Subjects will be randomized to receive the empagliflozin placebo for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin 25 MG
2018
Completed Phase 4
~390

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
451 Previous Clinical Trials
87,378 Total Patients Enrolled
Doris Duke Charitable FoundationOTHER
60 Previous Clinical Trials
260,080 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,378 Total Patients Enrolled

Media Library

Empagliflozin 25 MG (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05057806 — Phase < 1
Type 2 Diabetes Research Study Groups: Empagliflozin Group, Placebo group
Type 2 Diabetes Clinical Trial 2023: Empagliflozin 25 MG Highlights & Side Effects. Trial Name: NCT05057806 — Phase < 1
Empagliflozin 25 MG (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05057806 — Phase < 1

Frequently Asked Questions

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

Is participation in this research still open to new subjects?

"This clinical trial is aiming to enrol 30 subjects who suffer from heart failure with preserved ejection fraction and are between 18 - 80 years of age."

Answered by AI

Is this the inaugural instance of such a clinical trial?

"Empagliflozin 25 MG has been subject to scientific research since 2018, when Boehringer Ingelheim sponsored its first trial with 175 participants. Following the successful Phase 3 drug approval in that year, there are currently 49 active studies spanning 237 cities and 43 nations worldwide."

Answered by AI

Are there still vacancies for individuals to take part in this investigation?

"The trial is still open for recruitment, per the data available on clinicaltrials.gov. The medical research was first released to the public in January 2021 and had its latest update earlier this November 2022."

Answered by AI

Are elderly individuals being considered for participation in this trial?

"The conditions for enrollment in this medical trial necessitate that the patient is between 18 and 80 years old. There are 28 different trials available to patients below legal age, with 783 studies geared towards individuals over 65."

Answered by AI

What is the scope of the investigation into this therapy?

"Yes, as per the information on clinicaltrials.gov, this research endeavour is currently open for enrolment. It was first published on January 13th 2021 and has been updated most recently November 7th 2022. This trial seeks to have 30 participants from two separate locations."

Answered by AI

What is the empirical evidence regarding Empagliflozin 25 MG?

"Currently, 49 clinical trials are being conducted for the 25 MG dosage of Empagliflozin. Of these experiments, 13 have reached Phase 3 status. While Rosario in British Columbia holds a majority of the studies related to this medication, there is still research taking place at 1,012 venues worldwide."

Answered by AI

To what conditions is Empagliflozin 25 MG typically prescribed?

"Empagliflozin 25 MG is a useful therapeutic option for treating various heart-related conditions, including cardiovascular mortality, heart failure, and type 2 diabetes mellitus."

Answered by AI

What are the underlying goals of this research endeavor?

"The primary goal of this experiment, to be monitored from the start until 3 months later, is an alteration in Phosphodiester levels. Additionally, Cardiopulmonary Function (Change in oxygen uptake or VO2), Plasma Beta-hydroxybutyrate (β-OH-B) intensity (Change in β-OH-B) and 6 minute walk test performance (Distance covered over a 6 minute period) will all be measured as secondary objectives."

Answered by AI
~14 spots leftby Nov 2026