NCT05762952

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg Tab	Once daily oral dapagliflozin 10mg
DRUG	Placebo	Placebo capsules formulated by pharmacy to be indistinguishable from active drug

Timeline

• Start date: 2023-06-06
• Primary completion: 2025-08-05
• Completion: 2026-03-31
• First posted: 2023-03-10
• Last updated: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study