Antihyperglycemic Agent

Empagliflozin for Cardiovascular Disease

Diagnostic Assessment Centre (AMS Diagnostics), Toronto, Canada

Targeting 2 different conditionsEmpagliflozin +1 morePhase 4Waitlist AvailableLed by Subodh Verma, MD PhDResearch Sponsored by Unity Health Toronto

Eligibility Criteria Checklist

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

Must have

Female Not of childbearing potential and male subjects ≥ 18 and ≤ 85 years of age (Women Not of childbearing potential are females who are permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause or ≥6 weeks post-surgical bilateral oophorectomy prior to Screening.)

Major criteria

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow ups6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Study Summary

This trial will evaluate the effects of empagliflozin on cardiac structure, function, and circulating biomarkers in patients without diabetes but with cardiovascular risk factors.

Eligible Conditions

Cardiovascular Disease
Left Ventricular Hypertrophy

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow ups ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow ups ~ 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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

Left Ventricular (LV) mass

Secondary outcome measures

Hematocrit

LV diastolic function

LV end-diastolic volume

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: EmpagliflozinActive Control1 Intervention

Single 10 mg tablet, administered orally once daily for 6 months

Group II: PlaceboPlacebo Group1 Intervention

Single 10 mg tablet, administered orally once daily for 6 months

0 / 10Eligibility criteria met

Find a site

Who is running the clinical trial?

Applied Health Research CentreOTHER

22 Previous Clinical Trials

70,867 Total Patients Enrolled

Unity Health TorontoLead Sponsor

516 Previous Clinical Trials

378,862 Total Patients Enrolled

Canadian Medical and Surgical Knowledge Translation Research GroupOTHER

7 Previous Clinical Trials

680 Total Patients Enrolled

Boehringer IngelheimIndustry Sponsor

2,438 Previous Clinical Trials

10,447,980 Total Patients Enrolled

Subodh Verma, MD PhDPrincipal Investigator

Unity Health Toronto

Frequently Asked Questions

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

Is this research the initial foray into such a field of study?

"To date, there are 49 ongoing studies for Empagliflozin in 43 nations and 237 cities. This drug was first trialed by Boehringer Ingelheim back in 2018 with 175 participants and successfully attained Phase 3 approval status. Since then, an impressive 18,466 trials have been finished."

Answered by AI

What health conditions can be treated by utilizing Empagliflozin?

"Empagliflozin is the drug of choice for helping patients with cardiovascular diseases. Additionally, it has been show to reduce mortality from heart failure and diabetes mellitus type 2 (T2DM)."

Answered by AI

Are there any open slots to participate in this experiment?

"Affirmative. Records on clinicaltrials.gov confirm that this medical research is currently enrolling individuals, with the initial posting taking place on April 1st 2021 and the most recent edit occurring on June 14th 2021. This investigation requires 164 people to be recruited from 3 distinct locations."

Answered by AI

What is the current participation rate for this research endeavor?

"Yes, the information available on clinicaltrials.gov shows that this experiment is currently searching for participants. It was first posted in April 1st 2021 and has been revised more recently on June 14th of the same year. The trial requires 164 volunteers across 3 locations to be completed successfully."

Answered by AI

Is this study open to geriatric patients?

"Patients who are aged between 40 and 80 qualify to be enrolled in this trial."

Answered by AI

Have any prior investigations explored Empagliflozin's therapeutic potential?

"Currently, 49 clinical trials for Empagliflozin are in operation with 13 of them being Phase 3. The primary testing location is Quilmes, Maryland, though other research sites exist across the country and total 1,012."

Answered by AI

Has the FDA sanctioned Empagliflozin for use yet?

"Through our assessment at Power, we have determined that Empagliflozin is safe enough to receive a score of 3. This conclusion was made due to it being approved for use in Phase 4 clinical trials."

Answered by AI

Who is eligible to take part in this clinical trial?

"This clinical trial seeks 164 cardiovascular disease sufferers aged 40-80 to participate. To be eligible, participants must possess ECG evidence of LV hypertrophy as per the Sokolow-Lyon criteria and be willing to comply with scheduled visits and treatments. They also need an increased LVMi ≥96g/m2 for women and ≥116g/m2 for men (as calculated by echocardiogram or cMRI), structural heart disease defined as interventricular septal thickness or posterior wall thickness at end-diastole of ≥11 mm (as measured by 2D echocardiography or"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Empagliflozin and Cardiac Remodelling in People Without Diabetes

2021. "Empagliflozin and Cardiac Remodelling in People Without Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04461041.