Empagliflozin 25 MG for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Diabetes Institute - University Health System, San Antonio, TXHeart Failure+1 MoreEmpagliflozin 25 MG - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Diastolic Heart Failure
  • Type 2 Diabetes

Treatment Effectiveness

Study Objectives

5 Primary · 5 Secondary · Reporting Duration: Baseline to 3 months

Baseline to 3 months
6 minute walk test
ATPmax production
Acetoacetate concentrations
Cardiopulmonary Function
Change in Adenosine Triphosphate (ATP)
Change in Inorganic Phosphate
Change in Phosphocreatine
Change in Phosphodiester
Patient-Reported Outcomes Measure Information System (PROMIS)
Plasma Beta-hydroxybutyrate (β-OH-B)

Trial Safety

Side Effects for

Empagliflozin
17%Skin infection
17%Headache
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT04907214) in the Empagliflozin ARM group. Side effects include: Skin infection with 17%, Headache with 17%.

Trial Design

2 Treatment Groups

Empagliflozin Group
1 of 2
Placebo group
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Empagliflozin 25 MG · Has Placebo Group · Phase < 1

Empagliflozin Group
Drug
Experimental Group · 1 Intervention: Empagliflozin 25 MG · Intervention Types: Drug
Placebo group
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 3 months

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
405 Previous Clinical Trials
78,823 Total Patients Enrolled
3 Trials studying Heart Failure
126 Patients Enrolled for Heart Failure
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,186 Previous Clinical Trials
4,089,859 Total Patients Enrolled
3 Trials studying Heart Failure
227 Patients Enrolled for Heart Failure
Doris Duke Charitable FoundationOTHER
48 Previous Clinical Trials
233,231 Total Patients Enrolled
Carolina Solis-Herrera, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

Eligibility Criteria

Age 18 - 80 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have Type 2 diabetes.
Your body mass index (BMI) falls between 23 and 38, which is a range that indicates a healthy weight.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.