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

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05762952
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Myocardial Ischemia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 6, 2023
Status verified
Mar 2025
Primary completion
Aug 5, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin 10mg oral tablet.
  • Placebo Comparator: Placebo
    Placebo matching tablet.

Primary Outcome Measure

Change in myocardial perfusion reserve [ Time Frame: Baseline and after 12 weeks of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22908
Caroline L Flournoy
[email protected]
4349246104
Patricia Rodrguez, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Virginia· Charlottesville, VA

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