Dapagliflozin for Heart Attack Recovery

Overseen By Sarah Schwager, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Minneapolis Heart Institute Foundation

Must be taking: SGLT2 inhibitors

Must not be taking: SGLT2 inhibitors, Insulin

Disqualifiers: Previous CABG, Atrial fibrillation, Type 1 diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

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: 1

Duration: 6 months

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dapagliflozin, an SGLT2 inhibitor, can aid heart recovery after a heart attack. The study will focus on improving heart function and reducing heart enlargement. Participants will take either the medication or a placebo (a harmless pill resembling the medication) daily for six months. Individuals who have experienced their first heart attack and have mild heart function issues may be suitable for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using SGLT2 inhibitors.

Is there any evidence suggesting that dapagliflozin is likely to be safe for humans?

Research has shown that dapagliflozin is generally safe for people. One study found that patients taking dapagliflozin experienced fewer major heart problems compared to those taking a placebo, which contains no active medicine. Another study demonstrated that dapagliflozin significantly improved heart function and reduced serious heart issues after a heart attack, even in individuals without diabetes.

These findings suggest that dapagliflozin is safe for treating heart conditions. The FDA has also approved it for other uses, such as treating diabetes, which supports its safety profile. While it is important to be aware of possible side effects, the evidence so far is promising for dapagliflozin's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart attack recovery?

Dapagliflozin is unique because it offers a new approach to heart attack recovery by targeting the SGLT2 protein, which is primarily known for its role in diabetes management. Unlike the standard heart attack treatments that focus on improving blood flow or preventing clots, dapagliflozin works by reducing the heart's workload and potentially improving heart function and energy efficiency. Researchers are excited about dapagliflozin because it could provide additional benefits beyond what current medications offer, potentially leading to better recovery outcomes for heart attack patients.

What evidence suggests that dapagliflozin might be an effective treatment for heart attack recovery?

In this trial, participants in the treatment group will receive dapagliflozin. Research has shown that this medication can greatly improve heart health and reduce the risk of heart problems after a heart attack. Studies have found that dapagliflozin lowers the chance of dying from heart-related issues by 14% and decreases the likelihood of hospitalization for heart failure. These benefits apply to both individuals with and without diabetes. Overall, dapagliflozin has a strong record of aiding heart recovery and maintaining heart health. Participants in the placebo group will receive a placebo alongside standard heart attack medications. ^{5 6 7 8 9}

Who Is on the Research Team?

Jay Traverse, MD

Principal Investigator

Minneapolis Heart Institute Foundation

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who've had their first severe heart attack and received a procedure to open blocked arteries. They must have some heart muscle weakness and significant damage from the heart attack, but can't be on dialysis, pregnant, or have a life expectancy under one year. People with certain conditions like diabetes needing insulin or previous major heart issues aren't eligible.

Inclusion Criteria

You have a specific type of heart damage that is more than 10% of the size of the heart attack.

You have a weak heart with a low ejection fraction (LVEF < 50%) as shown in heart tests.

The size of the heart attack is more than 10% of the total mass of the left ventricle.

Exclusion Criteria

I have had heart bypass or valve surgery in the past.

You are not expected to live for more than 1 year.

I have had a major heart attack before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SGLT2 inhibitor or placebo once daily for six months

6 months

1 cardiac MRI during initial hospitalization, follow-up phone calls at 1 and 3 months, 1 cardiac MRI and clinic visit at 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dapagliflozin
• Placebo

Trial Overview The study tests if dapagliflozin improves heart function and reduces its enlargement after a heart attack compared to a placebo. Participants will take the medication daily for six months, undergo two cardiac MRI scans—one during hospitalization and another at six months—and receive follow-up calls.

How Is the Trial Designed?

Group I: Treatment Group Active Control 1 Intervention

Treatment group will receive SGLT2 inhibitor in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

Group II: Placebo Group Placebo Group 1 Intervention

Placebo Group will receive placebo in addition to standard heart attack medications for the duration of hospitalization and 6-month duration of the study.

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?

Minneapolis Heart Institute Foundation

Lead Sponsor

Trials

32

Recruited

15,700+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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 SGLT2 inhibitor for managing type 2 diabetes, showing consistent reductions in blood glucose levels and body weight over long-term follow-up periods of 1-4 years across various clinical trials.

It has a low risk of causing hypoglycemia and is generally well tolerated, although it can lead to genital infections, particularly in women, and is not recommended for patients with moderate to severe renal impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dapagliflozin: a review of its use in patients with type 2 diabetes. Plosker, GL.[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.

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 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]

Citations

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

Dapagliflozin improves cardiac function and reduces ... Dapagliflozin significantly enhances cardiac function and reduces adverse cardiovascular events in post-MI patients, independent of diabetes status.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024051910

Dapagliflozin ameliorates myocardial infarction injury ... Dapagliflozin (DAPA) has been demonstrated to reduce cardiovascular mortality and heart failure hospitalization rates in diabetic patients.

3. cureus.com cureus.com/articles/275510-dapagliflozin-in-heart-failure-and-acute-myocardial-infarction-a-systematic-review-of-the-association-in-diabetic-patients

Dapagliflozin in Heart Failure and Acute Myocardial Infarction In the study, treatment with dapagliflozin resulted in a significantly lower incidence of the primary outcome compared to placebo (16.3% vs.

4. thecardiologyadvisor.com thecardiologyadvisor.com/news/dapagliflozin-reduces-risk-for-t2dm-after-mi-regardless-of-glycemic-status-or-bmi/

Dapagliflozin Reduces Risk for T2DM After MI, Regardless ... Dapagliflozin was associated with a 1-year absolute risk reduction (ARR) of 1.4% among patients who were normoglycemic and 3.5% among those who ...

5. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2022/new-data-show-farxiga-significantly-lowers-the-risk-of-cardiovascular-death-in-patients-with-heart-failure.html

New data show FARXIGA significantly lowers the risk of ... The analysis showed that FARXIGA reduced the risk of CV death by 14% (p=0.01, absolute risk reduction [ARR] 1.5%) over the median follow-up of ...

6. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300286

Dapagliflozin in Myocardial Infarction without Diabetes or ... In summary, the DAPA-MI trial demonstrated a significant benefit of dapagliflozin in terms of cardiometabolic outcomes as compared with placebo ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11364978/

Dapagliflozin in Heart Failure and Acute Myocardial Infarction In the study, treatment with dapagliflozin resulted in a significantly lower incidence of the primary outcome compared to placebo (16.3% vs.

8. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.039996

Dapagliflozin and Cardiovascular Outcomes in Patients ... Sodium glucose transporter-2 inhibitors reduce the risk of major adverse cardiovascular events (MACE) in patients with type 2 diabetes ...

9. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2023/11/10/04/26/dapa-mi

Dapagliflozin in Patients With Myocardial Infarction The goal of the trial was to assess the safety and efficacy of dapagliflozin in improving cardiometabolic outcomes among patients with acute ...