Study of Dapagliflozin Compared to Placebo in Women With Symptoms of Heart Ischemia Without Blocked Arteries

What this Trial Is About

Researchers are evaluating the effects of dapagliflozin, a drug in the sodium-glucose cotransporter 2 inhibitor class, in women experiencing symptoms of myocardial ischemia without obstructive coronary artery disease. This randomized, double-blind, placebo-controlled Phase 1 trial aims to determine whether dapagliflozin improves coronary blood flow in these women. The study is conducted at a single center and sponsored by the University of Virginia. Participants will be randomly assigned to receive either a 12-week course of dapagliflozin 10mg oral tablets once daily or matching placebo tablets. Study assessments will take place at baseline, 6 weeks, and 12 weeks of treatment. Cardiac magnetic resonance imaging will be used to measure peak myocardial blood flow at rest and during pharmacological stress at the start and end of the 12-week treatment period. Symptom surveys and laboratory tests will also be collected at these timepoints. During the study, participants will be closely monitored for any adverse events. Researchers will assess changes in myocardial perfusion reserve from baseline to 12 weeks as the primary outcome. Other evaluations include symptom tracking and lab work at 6 and 12 weeks. All data will be recorded in a database and results published in a peer-reviewed journal. Participation involves multiple visits over the 12-week treatment period, with ongoing safety monitoring throughout.

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