Empagliflozin and Cardiac Remodelling in People Without Diabetes

Sponsor
Unity Health Toronto
Study ID
NCT04461041
Phase
PHASE4
Status
Completed

Conditions

  • Cardiovascular Diseases
  • Left Ventricular Hypertrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Single oral tablet
  • Placebo — DRUG
    Placebo tablet manufactured to mimic empagliflozin 10 mg tablet

Study Details

The purpose of this study is to evaluate the effects of empagliflozin on cardiac structure, function and circulating biomarkers in patients with cardiovascular risk factors, but without diabetes. Empagliflozin is an antihyperglycemic agent approved by Health Canada and the FDA for the treatment of type 2 diabetes. Previous post-marketing clinical trials demonstrated a reduction in cardiovascular deaths and heart failure in patients with type 2 diabetes treated with empagliflozin. In the first EMPA-HEART trial, we demonstrated that empagliflozin reduces cardiac mass in patients with type 2 diabetes, as seen through cardiac magnetic resonance imaging (cMRI). Therefore, the aim of this study, EMPA-HEART 2, is to determine whether empagliflozin can similarly impact cardiac structure in patients without diabetes, but with various cardiovascular risk factors.

Key Dates

Start date
Apr 1, 2021
Status verified
Feb 2023
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022

Study Design

Enrollment
169 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: Empagliflozin
    Single 10 mg tablet, administered orally once daily for 6 months
  • Placebo Comparator: Placebo
    Single 10 mg tablet, administered orally once daily for 6 months

Primary Outcome Measure

Left Ventricular (LV) mass [ Time Frame: 6 months ]

Related Studies