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SGLT2 Inhibitor

Dapagliflozin for Heart Attack Recovery

Phase 2

Recruiting

Led By Jay Traverse, MD

Research Sponsored by Minneapolis Heart Institute Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with their first STEMI (> 18 years and < 75 years) who underwent successful primary PCI and able to give informed consent

Be older than 18 years old

Must not have

Previous CABG or Valve Surgery

Previous STEMI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial will test if dapagliflozin can improve heart function and reduce enlargement after a heart attack. Participants will take the medication or a placebo once daily for six months and have follow-up MRI tests and clinic visits.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dapagliflozin may cause urinary tract infections, dehydration leading to low blood pressure, yeast infections in women, increased cholesterol levels, kidney problems and rare cases of diabetic ketoacidosis even in those without diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a major heart attack before.

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I am currently experiencing unresolved cardiogenic shock.

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My kidney function is very low or I am on dialysis.

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I have irregular heartbeats or repeated serious heart rhythm problems.

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I have type 1 diabetes or have had diabetic ketoacidosis.

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I have diabetes and use insulin.

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I am currently taking SGLT2 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 LVEDVI

Change in LVESVI

Secondary study objectives

Change in LV mass

Change in LVEF

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment GroupActive Control1 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 GroupPlacebo Group1 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.

0 / 9Eligibility criteria met