Dapagliflozin for Angina

(STRONG Trial)

Overseen By Patricia Rodriguez-Lozano, MD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Virginia

Disqualifiers: Cardiomyopathy, Heart failure, Diabetes, others

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dapagliflozin, an SGLT2 inhibitor, can improve heart-related symptoms in women with coronary microvascular disease. Researchers aim to determine if dapagliflozin can ease chest pain and enhance quality of life for those without major artery blockages. Participants will receive either dapagliflozin or a placebo to compare effects. Women who have experienced chest pain and have had heart tests showing no major blockages might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this treatment.

Do I need to stop my current medications to join the trial?

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Studies have shown that dapagliflozin, the treatment being tested, is generally safe for people. It often helps with heart and kidney problems. Research indicates that it can lower the risk of heart failure and improve heart health. In previous studies, dapagliflozin also reduced the number of people experiencing chest pain (angina) compared to those who did not take it.

While dapagliflozin is usually well-tolerated, some people may experience side effects, such as low blood sugar and a serious condition called diabetic ketoacidosis (DKA), especially in those with diabetes. However, these side effects are uncommon. Overall, dapagliflozin's safety remains consistent across the different conditions it treats. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for angina?

Dapagliflozin is unique because it represents a novel approach for managing angina, a condition traditionally treated with medications like beta-blockers, calcium channel blockers, and nitrates. While these standard treatments primarily work by improving blood flow to the heart, dapagliflozin is an SGLT2 inhibitor originally used to manage diabetes by helping the kidneys remove glucose from the bloodstream. Researchers are excited because dapagliflozin may offer cardiovascular benefits by reducing heart workload and improving heart function, potentially offering relief for angina symptoms in a new way. This different mechanism of action makes it an exciting candidate for providing additional therapeutic options for those with angina.

What evidence suggests that dapagliflozin might be an effective treatment for angina?

This trial will compare dapagliflozin with a placebo to evaluate its effects on angina. Studies have shown that dapagliflozin benefits heart health. In individuals with heart failure and type 2 diabetes, it lowers the risk of heart problems. Research indicates it can reduce blood markers like NT-proBNP and hs-CRP, which are linked to heart stress and inflammation. Dapagliflozin also improves heart function by enhancing its pumping ability and reducing its size. These effects suggest it might alleviate chest pain related to small blood vessel issues in the heart. ^{6 7 8 9 10}

Who Is on the Research Team?

Patricia Rodriguez-Lozano, MD

Principal Investigator

Uni

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Diagnosis of CMD defined by CFR < 2 by CMR

I am female.

I have never taken SGLT2 inhibitors for diabetes.

Exclusion Criteria

Implanted cardiac device

I am currently receiving treatment for cancer.

I have a serious heart valve problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Dapagliflozin or placebo for 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

Trial Overview 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).

How Is the Trial Designed?

Group I: Active Drug Group Experimental Treatment 1 Intervention

Brezavvy 20mg oral tablet

Group II: Placebo Group Placebo Group 1 Intervention

placebo tablet

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

Approved in European Union as Forxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in United States as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dapagliflozin (forxiga®) : SGLT 2 cotransporter inhibitor as glucose-lowering agent in type 2 diabetes]. Scheen, AJ.[2021]

Dapagliflozin (Farxiga) is approved for reducing the risk of declining kidney function and kidney failure in adults with chronic kidney disease, regardless of whether they have type 2 diabetes.

It also helps lower the risk of cardiovascular death and hospitalization for heart failure, highlighting its efficacy in managing both kidney and heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antidiabetic Drug Approved to Reduce Risk of Kidney Disease. Aschenbrenner, DS.[2023]

Dapagliflozin (DAPA) is an effective SGLT2 inhibitor for treating type 2 diabetes, showing favorable pharmacokinetics and pharmacodynamics that help lower blood sugar levels while having beneficial effects on other metabolic risk factors.

While DAPA is generally safe, it carries an increased risk of genital and urinary infections, and concerns about bladder cancer and cardiovascular safety remain, prompting the FDA to seek further data on these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. Maranghi, M., Carnovale, A., Durante, C., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. Davis, PN., Ndefo, UA., Oliver, A.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Review in Symptomatic Heart Failure with Reduced Ejection Fraction. Blair, HA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12173874/

Dapagliflozin improves cardiac function and reduces ... Our data indicate that dapagliflozin effectively reduces NT-proBNP and hs-CRP levels, while increasing LVEF and decreasing LVEDD and LVESD. NT- ...

2. withpower.com withpower.com/trial/phase-1-myocardial-ischemia-2025-5c34b

Dapagliflozin for Angina (STRONG Trial) Dapagliflozin has shown cardiovascular benefits in patients with heart failure and type 2 diabetes, reducing the risk of heart-related death or hospitalization.

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.068613

Comparative Cardiovascular Effectiveness of Empagliflozin ... Empagliflozin and dapagliflozin initiators had no differences in 6-year cardiovascular outcomes in adults with treated type 2 diabetes.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538721/

Results - Clinical Review Report: Dapagliflozin (Forxiga) - NCBI There was a statistically significantly greater reduction from baseline in FPG at week 24 in the dapagliflozin group compared with the placebo group (adjusted ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224008783

SGLT2 inhibitor Dapagliflozin alleviates cardiac ... DPG promotes angiogenesis by activating PXR, thereby alleviating cardiac dysfunction and fibrosis after myocardial infarction.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4761166/

Cardiovascular effects of dapagliflozin in patients with type ... Dapagliflozin is not associated with increased CV risk and results further suggest the potential for a beneficial effect both in the overall population.

7. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2025.1594861/full

Dapagliflozin improves cardiac function and reduces ... Dapagliflozin significantly reduced angina pectoris incidence compared to controls (RR = 0.34, 95% CI [0.13, 0.88], P < 0.05) (Figure 7b).

8. ajmc.com ajmc.com/view/diabetes-drug-farxiga-cuts-heart-risks-in-topline-results

Diabetes Drug Farxiga Cuts Heart Risks in Topline Results In addition, dapagliflozin achieved a statistically significant reduction in a composite endpoint of hospitalization for heart failure or CV ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf

CENTER FOR DRUG EVALUATION AND RESEARCH The overall safety profile of FARXIGA was consistent across the studied indications. Severe hypoglycemia and diabetic ketoacidosis (DKA) were.

10. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.051675

Effect of Dapagliflozin on Clinical Outcomes in Patients ... Dapagliflozin reduced the risk of kidney failure, death from cardiovascular causes or hospitalization for heart failure, and prolonged survival in people with ...