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SGLT2 Inhibitor

Dapagliflozin for Angina (STRONG Trial)

Phase 1
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female sex
Age ≥18 years
Must not have
Active malignancy requiring treatment at the time of visit
Severe (eGFR <30 mL/min/1.73 m2 by CKD-EPI), unstable, or rapidly progressing renal disease at the time of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to 12 weeks

Summary

This trial aims to study how a new class of drugs, Sodium-glucose cotransporter 2 inhibitors, may benefit women with anginal symptoms and non-obstructive coronary artery disease. These women

Who is the study for?
The STRONG trial is for women with anginal symptoms and non-obstructive coronary disease, which means their heart's blood vessels are not blocked but they still have chest pain. Participants should be experiencing major discomfort and a reduced quality of life due to these heart issues.
What is being tested?
This study tests if a diabetes drug called Dapagliflozin can help improve heart blood flow and reduce chest pain in women with this specific type of heart disease. It compares the effects of Dapagliflozin against a placebo (a pill without any active drug).
What are the potential side effects?
Dapagliflozin may cause side effects like urinary tract infections, dehydration, low blood pressure, kidney problems, increased cholesterol levels, and potential risk of bone fractures or diabetic ketoacidosis in those with diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I am 18 years old or older.
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I have never taken SGLT2 inhibitors for diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving treatment for cancer.
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My kidney function is severely impaired.
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I have not had a stroke or brain bleed in the last 6 months.
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I have a serious heart valve problem.
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I have had repeated UTI or kidney infections.
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My heart beats fewer than 40 times a minute.
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I have an irregular heartbeat detected during imaging.
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I have a heart condition with reduced or thickened heart muscle.
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I have type 1 diabetes.
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I have a history of heart failure, severe lung or liver disease.
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My doctor expects I have more than 3 years to live, not considering heart issues.
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I often feel dizzy or faint due to low blood pressure.
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I have asthma with current wheezing.
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I have a lung condition like severe asthma, ARDS, or emphysema.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Coronary Flow Reserve

Side effects data

From 2021 Phase 4 trial • 324 Patients • NCT03030235
9%
Exacerbation of Heart Failure
6%
Volume Depletion
5%
Acute Kidney Injury
5%
Urgent Heart Failure Visit
2%
Atrial Fibrillation
1%
Diverticulitis
1%
Gastroenteritis
1%
Acute Renal Failure
1%
Covid-19
1%
Clostridium Difficile
1%
Diarrhea
1%
Abdominal Wall Hematoma
1%
Acute Respiratory Distress
1%
Elevated Troponin in the setting of Covid-19
1%
Hemochromatosis
1%
Melena and hematochezia
1%
Sepsis
1%
Septicemia
1%
Syncope
1%
Hemoptysis
1%
Hyperglycemia
1%
Non cardiac chest pain
1%
Hypercapnic and hypoxic respiratory failure requiring intubation
1%
Osteoarthritis (Right Hip)
1%
Osteomyelitis (left foot)
1%
Parainfluenza
1%
Suicidal Ideation
1%
Type II NSTEMI
1%
Uncontrolled Hypertension
1%
Urinary frequency
1%
Blurry vision
1%
Schwannoma of spinal cord at L1-L2
1%
Worsening Osteoarthritis - Left Knee
1%
Nausea
1%
Fatigue
1%
Atrial Flutter
1%
Benign Paroxysmal Positional Vertigo
1%
Breast Cancer
1%
Cellulitis
1%
Hypotension
1%
Iron Overload cardiomyopathy
1%
Left hilar mass
1%
Pancreatitis
1%
Pneumonia
1%
Prostate Cancer
1%
Upper Respiratory Infection
1%
Ventricular Tachycardia
1%
Hypertensive Crisis
1%
Leg pain
1%
Foul smelling urine
1%
Sense of hopelessness
1%
Back Pain
1%
Right Shoulder - Infected Arthroplasty
1%
Neck Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Drug GroupExperimental Treatment1 Intervention
Dapagliflozin 10mg oral tablet
Group II: Placebo GroupPlacebo Group1 Intervention
placebo tablet
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10Mg Oral Tablet
2017
Completed Phase 4
~330

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,552 Total Patients Enrolled
~100 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
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