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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• Willing to provide written informed consent.

• Signs and symptoms of suspected ischemia that prompted referral for further evaluation by cardiac catheterization or coronary computed tomography within two years of consent.

• No evidence of obstructive epicardial coronary artery disease (stenosis \>50%) of a major epicardial vessel (\>3mm) or a fractional flow reserve \>0.80 by invasive catheterization or coronary computed tomography. (Participants who have not undergone cardiac catheterization or coronary angiogram within the last 2 years for their clinical care will be screened with computed angiogram of the coronary arteries to confirm eligibility).

• Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment

• For subjects having a history of type 2 diabetes mellitus: approval of diabetes care/prescribing provider

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Caroline L Flournoy, PhD
clf4w@uvahealth.org
4349246104
Backup
Nicole J Sprouse, RN
njb6m@uvahealth.org
434-982-1058
Time Frame
Start Date: 2023-06-06
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: Dapagliflozin
Dapagliflozin 10mg oral tablet.
Placebo_comparator: Placebo
Placebo matching tablet.
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov