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Sodium-Glucose Cotransporter 2 Inhibitor

Dapagliflozin for Coronary Artery Disease (SMILE Trial)

Phase 1
Recruiting
Led By Caroline L Flournoy, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Signs and symptoms of suspected ischemia that prompted referral for further evaluation by cardiac catheterization or coronary computed tomography within two years of consent
Estimated glomerular filtration rate ≥30ml/min/1.73m2 at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 12 weeks of treatment
Awards & highlights

SMILE Trial Summary

This trial will test a drug to improve blood flow in women with ischemic heart disease. Participants will take the drug or placebo for 12 weeks and have scans to measure heart blood flow.

Who is the study for?
This trial is for women with symptoms of ischemic heart disease but no major blockages in their heart arteries. They must have suspected ischemia, a decent kidney function, and if diabetic, approval from their diabetes doctor. It's not for those with severe heart failure, recent acute coronary syndrome or stroke, certain chronic diseases, low blood pressure, frequent urinary infections, type 1 diabetes or active cancer.Check my eligibility
What is being tested?
The study tests whether Dapagliflozin improves blood flow in the heart compared to a placebo over 12 weeks. Women will be randomly given either the drug or placebo and monitored using stress cardiac MRI at the start and end of the trial to measure any changes in heart blood flow.See study design
What are the potential side effects?
While specific side effects are not listed here, drugs like Dapagliflozin can typically cause urinary tract infections, dehydration leading to low blood pressure (hypotension), potential kidney issues and an increased risk of diabetic ketoacidosis in diabetics.

SMILE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was referred for a heart check-up due to suspected blockage signs within the last 2 years.
Select...
My kidney function is at a safe level for the trial.
Select...
My heart's major arteries are not significantly blocked.

SMILE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 12 weeks of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after 12 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in myocardial perfusion reserve

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

SMILE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapagliflozinExperimental Treatment1 Intervention
Dapagliflozin 10mg oral tablet.
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10mg Tab
2022
Completed Phase 4
~950

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,000 Total Patients Enrolled
1 Trials studying Myocardial Ischemia
150 Patients Enrolled for Myocardial Ischemia
Caroline L Flournoy, MDPrincipal InvestigatorUniversity of Virginia Health System

Media Library

Dapagliflozin 10mg Tab (Sodium-Glucose Cotransporter 2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05762952 — Phase 1
Myocardial Ischemia Research Study Groups: Placebo, Dapagliflozin
Myocardial Ischemia Clinical Trial 2023: Dapagliflozin 10mg Tab Highlights & Side Effects. Trial Name: NCT05762952 — Phase 1
Dapagliflozin 10mg Tab (Sodium-Glucose Cotransporter 2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05762952 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the effects of Dapagliflozin on patient health?

"Our team at Power has assessed the safety of Dapagliflozin to be a 1 due to it being in a Phase 1 clinical trial, wherein limited data is available regarding its efficacy and safety."

Answered by AI

Can I be accepted as a participant in this medical trial?

"This medical trial is accepting 40 participants with myocardial ischemia, who are aged between 18 and 99."

Answered by AI

Does this trial include elderly individuals or is there an age limit?

"This clinical trial is open to adults aged 18-99. For those who are under the legal age of adulthood, there are 46 studies that may be applicable and 882 for seniors aged 65+."

Answered by AI

Are there still enrollments available for this clinical research?

"Correct. According to clinicaltrials.gov, this medical study is now open for recruitment and was initially posted on May 24th 2023. 40 participants are needed from 1 site with the last edit occuring on May 8th 2023."

Answered by AI

What is the magnitude of participants involved in this research?

"Affirmative, the information hosted on clinicaltrials.gov declares that recruitment for this medical trial is happening now. The study was launched on May 24th 2023 and last updated a few weeks later on May 8th. 40 individuals are being sought from 1 distinct location to take part in the experiment."

Answered by AI
~4 spots leftby Apr 2024