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Empagliflozin and Cardiac Remodelling in People Without Diabetes

NCT04461041 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2023-02-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Empagliflozin

Single oral tablet

DRUG

Placebo

Placebo tablet manufactured to mimic empagliflozin 10 mg tablet

Sponsors & Collaborators

  • Canadian Medical and Surgical Knowledge Translation Research Group

    collaborator OTHER

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • Applied Health Research Centre

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Subodh Verma, MD PhD · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Canada
  • Taiwan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461041 on ClinicalTrials.gov