40 Participants Needed

Dapagliflozin for Coronary Artery Disease

(SMILE Trial)

CL
NJ
Overseen ByNicole J Sprouse, RN
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: University of Virginia
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether dapagliflozin, a drug that lowers blood sugar, can improve heart blood flow in women who have heart disease symptoms but no blocked arteries. Participants will take the drug for a few months, and their heart blood flow will be measured at the start and end of the study. Dapagliflozin has been shown to help manage blood sugar levels and improve heart health in patients with type 2 diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is dapagliflozin generally safe for humans?

Dapagliflozin, also known as Farxiga, is generally well tolerated in humans. It has been used safely in treating conditions like heart failure and type 2 diabetes, although it may cause some side effects like genital infections, especially in women, and is not recommended for people with moderate or severe kidney problems.12345

How does the drug Dapagliflozin differ from other treatments for coronary artery disease?

Dapagliflozin is unique because it is primarily used for managing type 2 diabetes by helping the kidneys remove glucose from the bloodstream, which is different from traditional coronary artery disease treatments like beta-blockers or nitrates that focus on reducing heart workload and improving blood flow.678910

What evidence supports the effectiveness of the drug dapagliflozin for coronary artery disease?

Dapagliflozin has shown benefits in reducing the risk of cardiovascular death and hospitalization for heart failure in patients with heart failure and type 2 diabetes, as seen in the DECLARE-TIMI 58 and DAPA-HF trials. These cardiovascular benefits suggest potential effectiveness for coronary artery disease, although direct evidence for this specific condition is not provided.1231112

Who Is on the Research Team?

PR

Patricia Rodriguez-Lozano, MD

Principal Investigator

University of Virginia Health System

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to provide written informed consent
I was referred for a heart check-up due to suspected blockage signs within the last 2 years.
My kidney function is at a safe level for the trial.
See 2 more

Exclusion Criteria

I have a serious heart valve condition.
I often feel faint due to low blood pressure below 95 mmHg.
I have type 2 diabetes and have had diabetic ketoacidosis.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week course of dapagliflozin 10mg or placebo. Blood flow in the heart is assessed using stress cardiac magnetic resonance imaging at baseline and 12 weeks.

12 weeks
3 visits (in-person) at baseline, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Dapagliflozin 10mg Tab
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapagliflozinExperimental Treatment1 Intervention
Dapagliflozin 10mg oral tablet.
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching tablet.

Dapagliflozin 10mg Tab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Farxiga for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇺🇸
Approved in United States as Farxiga for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
  • Heart failure with preserved ejection fraction
  • Heart failure with mildly reduced ejection fraction
🇨🇦
Approved in Canada as Farxiga for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction
  • Chronic kidney disease
🇯🇵
Approved in Japan as Farxiga for:
  • Type 2 diabetes mellitus
  • Heart failure with reduced ejection fraction

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Published Research Related to This Trial

Dapagliflozin, an SGLT2 inhibitor, has been shown to significantly reduce the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with reduced ejection fraction (HFrEF), regardless of whether they have type 2 diabetes.
In the DAPA-HF trial, dapagliflozin was well tolerated and demonstrated a lower risk of worsening heart failure or cardiovascular death compared to placebo, making it a valuable treatment option for adults with symptomatic HFrEF.
Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction.Blair, HA.[2022]
Dapagliflozin is an effective treatment for type 2 diabetes, proven through multiple controlled clinical trials that assess its efficacy, safety, and tolerability.
It is approved by the FDA for use as a standalone therapy or in combination with other glucose-lowering medications, including insulin.
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus.Davis, PN., Ndefo, UA., Oliver, A.[2021]
Dapagliflozin effectively lowers blood sugar levels and glycated hemoglobin (HbA1c) in patients with type 2 diabetes, with a low risk of hypoglycemia and additional benefits like weight loss and reduced blood pressure.
While it is generally safe, dapagliflozin can increase the risk of genital infections, particularly in women, and its efficacy may be reduced in patients with kidney issues; ongoing trials are investigating its potential cardiovascular and renal protective effects.
[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes].Scheen, AJ.[2021]

Citations

Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. [2022]
Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]
[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. [2021]
Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. [2023]
Beyond the Glycaemic Control of Dapagliflozin: Impact on Arterial Stiffness and Macroangiopathy. [2022]
Dapagliflozin: a review of its use in patients with type 2 diabetes. [2022]
Dapagliflozin for the Treatment of Type 2 Diabetes Mellitus. [2019]
Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). [2022]
[Risk management of coronary artery disease--pharmacological therapy]. [2019]
10.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Use of transesophageal electrostimulation of the heart for evaluating the effectiveness of anti-anginal therapy]. [2017]
11.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Stable angina pectoris: current medical treatment. [2018]
Recent developments in the use of calcium antagonists in myocardial protection. [2019]
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