NCT05762952

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 22, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

January 9, 2023

Last Update Submit

August 18, 2025

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • Change in myocardial perfusion reserve

    Myocardial microvascular perfusion, defined as myocardial perfusion reserve as assessed by stress cardiac magnetic resonance imaging

    Baseline and after 12 weeks of treatment

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg oral tablet.

Drug: Dapagliflozin 10mg Tab

Placebo

PLACEBO COMPARATOR

Placebo matching tablet.

Drug: Placebo

Interventions

Dapagliflozin 10mg TabDRUG

Once daily oral dapagliflozin 10mg

Also known as: active drug
Dapagliflozin
PlaceboDRUG

Placebo capsules formulated by pharmacy to be indistinguishable from active drug

Also known as: Placebo matching tablet
Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of non-ischemic cardiomyopathy with left ventricular ejection fraction \<40% or hypertrophic cardiomyopathy.
  • History of congestive heart failure, severe pulmonary disease, liver disease
  • History of Acute coronary syndrome within previous 30 days
  • Stroke within the last 180 days or intracranial hemorrhage at any time.
  • Severe Valvular disease
  • Life expectancy \<3 years, due to non-cardiovascular comorbidity.
  • Pregnancy or women who are breast-feeding
  • Type 1 diabetes mellitus
  • History of diabetic ketoacidosis in subjects with Type 2 Diabetes Mellitus
  • Symptomatic hypotension or systolic blood pressure \<95 mmHg on 2 consecutive measurements
  • Active malignancy requiring treatment at the time of visit
  • Severe, unstable, or rapidly progressing renal disease at the time of randomization
  • History of recurrent urinary tract, bladder, or kidney infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

dapagliflozinBulk Drugs

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Patricia Rodriguez-Lozano, MD

    University of Virginia Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline L Flournoy, PhD

CONTACT

4349246104clf4w@uvahealth.org

Nicole J Sprouse, RN

CONTACT

434-982-1058njb6m@uvahealth.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Pharmacy will manage the randomization of study participants. Assignments will not be unmasked until all outcomes have been assessed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

January 9, 2023

First Posted

March 10, 2023

Study Start

June 6, 2023

Primary Completion

August 5, 2025

Study Completion

March 31, 2026

Last Updated

August 22, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)