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

Trial Summary

What is the purpose of this trial?

The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.

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.

What data supports the effectiveness of the drug Dapagliflozin for heart attack recovery?

Dapagliflozin has been shown to reduce the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with reduced ejection fraction, regardless of whether they have type 2 diabetes. This suggests it may help in heart attack recovery by improving heart health and reducing related risks. ^{1 2 3 4 5}

How does the drug dapagliflozin differ from other treatments for heart attack recovery?

Dapagliflozin is unique because it is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that not only helps manage blood sugar levels in diabetes but also provides cardiovascular benefits, such as reducing the risk of heart failure and cardiovascular death, which is not typical for most diabetes medications. ^{1 2 3 4 6}

Research Team

Jay Traverse, MD

Principal Investigator

Minneapolis Heart Institute Foundation

Eligibility Criteria

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.

I am between 18 and 75 years old, had a first heart attack, and underwent a successful procedure to open my heart's arteries.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, pharmacodynamics and clinical efficacy of dapagliflozin for the treatment of type 2 diabetes. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Dapagliflozin: A Sodium Glucose Cotransporter 2 Inhibitor for the Treatment of Diabetes Mellitus. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Dapagliflozin: a review of its use in patients with type 2 diabetes. [2022]