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SGLT2 Inhibitors for Heart Failure
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 1 & 2 trial • 29 Patients • NCT04907214Trial Design
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Who is running the clinical trial?
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- My heart failure medication dose has been stable.I am between 18 and 80 years old.I am currently taking medication for diabetes that includes SGLT2 inhibitors, GLP-1 receptor agonists, or pioglitazone.Your kidney function is good, with a filtration rate of at least 30 ml/min•1.73 m2.Your weight has not changed by more than 4 pounds in the last 3 months.Your HbA1c levels are between 5.5% and 10%.Your body mass index (BMI) is between 23 and 38.I have moderate to severe heart failure with an ejection fraction below 50%.Your blood pressure is too high (systolic BP>180mmHg and/or diastolic BP >100mmHg).I have a physical disability that makes it unsafe for me to do certain exercises.I have Type 2 Diabetes.Your blood pressure should be less than 145/85 mmHg.Your heart beats more than 120 times per minute when you are at rest.Your blood oxygen level at rest is less than 85%.
- Group 1: Empagliflozin Group
- Group 2: Placebo group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
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."
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."
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."
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