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Effect of Dapagliflozin on Microvascular Function in Women With Symptoms of Coronary Artery Disease — SMILE  

Myocardial Ischemia Clinical Trial

Official title:
A Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate Microvascular Disease After 12 Weeks of Therapy With Sodium-glucose Co-transporter 2 Inhibitor Compared to Placebo in Symptomatic Women With Non-obstructive Coronary Artery Disease

Clinical Trial Summary

The goal of this clinical trial is to test the effects of a drug (in the drug class called sodium-glucose cotransporter 2 inhibitors) in women who have symptoms of ischemic heart disease. The main questions the study aims to answer are: Does blood flow in the heart improve with study drug? Participants will be randomly assigned to a 12-week course of the study drug, dapagliflozin 10mg, or placebo. Blood flow in the heart will be assessed using stress cardiac magnetic resonance imaging at baseline and 12 weeks. The researchers will compare the results from the two groups.

Clinical Trial Description

This single-center clinical investigation is a randomized, double-blind, placebo controlled trial of dapagliflozin in women who have symptoms of myocardial ischemia but in whom obstructive coronary artery disease has been ruled out by testing within 2 years. Aim: Determine whether dapagliflozin improves coronary blood flow in women. Participants will be randomly assigned to a 12-week course of dapagliflozin 10mg oral or placebo. Participants will complete study assessments at baseline, 6 weeks of treatment, and 12 weeks of treatment. Peak myocardial blood flows at rest and with pharmacological stress will be assessed using cardiac magnetic resonance imaging at baseline and 12 weeks. Symptom surveys and lab work will be collected at baseline, 6 weeks, and 12 weeks of treatment. Participants will be closely monitored throughout study participation for adverse events. Results will be captured in a database and published in a peer-reviewed journal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05762952
Study type Interventional
Source University of Virginia
Contact Caroline L Flournoy, PhD
Phone 4349246104
Email clf4w@uvahealth.org
Status Recruiting
Phase Phase 1
Start date June 6, 2023
Completion date March 31, 2025
View Details
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