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Anti-hyperglycemic agent

Empagliflozin for Diabetes (EMPA-HEART Trial)

Phase 4
Waitlist Available
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

EMPA-HEART Trial Summary

The purpose of this study is to evaluate the effects of Empagliflozin on cardiac structure, function and circulating biomarkers in patients with Type II diabetes. Empagliflozin (anti-hyperglycemic agent), approved by Health Canada and the FDA for the treatment of Type II diabetes, demonstrated a reduction in cardiovascular deaths and heart failure from a previous post-marketing clinical trial. The use of empagliflozin to treat patients with diabetes and heart disease has been approved by Health Canada. However, the process by which it may give this beneficial effect remains unclear and needs further investigation. Therefore, the aim of this study is to provide a fundamental understanding of the mechanistic basis by which Empagliflozin could provide its potential cardio-protective effects by employing the use of Cardiac Magnetic Resonance Imaging (CMRI).

Eligible Conditions
  • Diabetes
  • Cardiovascular Disease

EMPA-HEART Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Cerebral Ventricles
Secondary outcome measures
Aortic pulse wave velocity and distensibility
Biomarkers
End-systolic volume (indexed to BSA)
+5 more

EMPA-HEART Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: EmpagliflozinActive Control1 Intervention
The study medication (Jardiance) is the only diabetes medication to show a significant reduction in both cardiovascular risk and cardiovascular death. The generic name is empagliflozin and will be provided by Boehringer-Ingelheim. If the patient is randomized into the study drug group patients will receive empagliflozin 10 mg tablets once daily for a duration of 6 months.
Group II: PlaceboPlacebo Group1 Intervention
The placebo group acts as a control group. This is in order to objectively isolate empagliflozin's effect on cardiac structure and function as determined by CMR imaging.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
540 Previous Clinical Trials
447,683 Total Patients Enrolled
13 Trials studying Diabetes
4,033 Patients Enrolled for Diabetes
Boehringer IngelheimIndustry Sponsor
2,507 Previous Clinical Trials
11,340,810 Total Patients Enrolled
4 Trials studying Diabetes
204,001 Patients Enrolled for Diabetes

Frequently Asked Questions

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~12 spots leftby May 2025