Faculty Collaboration Database

Study rationale and design of a study of EMPAgliflozin's effects in patients with type 2 diabetes mellitus and Coronary ARtery disease: the EMPA-CARD randomized controlled trial. BMC Cardiovasc Disord 2021 Jun 30;21(1):318

Date

07/02/2021

Pubmed ID

34193056

Pubmed Central ID

PMC8242278

DOI

10.1186/s12872-021-02131-1

Scopus ID

2-s2.0-85109047083 (requires institutional sign-in at Scopus site)   4 Citations

Abstract

BACKGROUND: Recent trials have revealed that sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are effective against hyperglycemia and also reduce micro- and macro-vascular complications in patients with type 2 diabetes mellitus (T2DM). Most of the beneficial cardiovascular effects have been investigated in patients with heart failure and coronary artery disease (CAD). Yet, few human studies have been conducted to investigate the molecular mechanisms underlying these clinically beneficial effects in patients with CAD. Accordingly, the EMPA-CARD trial was designed to focus on the molecular effects of empagliflozin in patients with T2DM and CAD.

METHODS: In this multicenter, triple-blind randomized controlled trial, patients with documented known T2DM and CAD will be recruited. They will be randomized on a 1:1 ratio and assigned into two groups of empagliflozin 10 mg/daily and placebo. The primary endpoint is the effect of empagliflozin on changes of plasma interleukin 6 (IL-6) after 26 weeks of treatment. The secondary endpoints will consist of changes in other inflammatory biomarkers (Interleukin 1-beta and high-sensitive C-reactive protein), markers of oxidative stress, platelet function, and glycemic status.

DISCUSSION: The EMPA-CARD trial mainly tests the hypothesis that SGLT2 inhibition by empagliflozin may improve inflammatory status measured as reduction in inflammatory biomarkers in patients with T2DM and CAD. The results will provide information about the underlying mechanisms of SGLT2 inhibition that mediate the beneficial effects of this medication on clinical outcomes.

TRIAL REGISTRATION: Iranian Registry of Clinical Trials. www.IRCT.ir , Identifier: IRCT20190412043247N2. Registration Date: 6/13/2020. Registration timing: prospective.

Author List

Gohari S, Reshadmanesh T, Khodabandehloo H, Fathi M, Ahangar H, Arsang-Jang S, Ismail-Beigi F, Ghanbari S, Dadashi M, Muhammadi MJ, Gohari S, Ghaffari S

Author

Shahram Arsang-Jang Postdoctoral Fellow in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Benzhydryl Compounds
Biomarkers
Blood Glucose
Coronary Artery Disease
Diabetes Mellitus, Type 2
Disease Progression
Female
Glucosides
Humans
Inflammation Mediators
Iran
Male
Middle Aged
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Time Factors
Treatment Outcome