Can a diabetes drug shield the heart during a heart attack procedure?
NCT ID NCT07749014
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests whether giving empagliflozin before or after a procedure to open a blocked heart artery (primary PCI) reduces heart muscle injury during a heart attack. Adults aged 18-75 of South Asian origin having their first heart attack will be randomly assigned to receive empagliflozin before the procedure, after it, or a placebo. Researchers will measure heart damage via blood tests and heart scans over 90 days to see if the timing of the drug matters.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin (an SGLT2 inhibitor drug, also known as Jardiance)
- What this could lead to
- If timing empagliflozin before the artery-opening procedure reduces heart muscle damage, it could become a standard part of heart attack care, potentially improving recovery and reducing long-term heart failure risk.
- What could go wrong
- This is a phase 2 trial, so results are preliminary. The benefit may be small or not appear, and empagliflozin can have side effects like urinary infections or dehydration. Findings in South Asian patients may not apply to other populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 480 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-75 years at presentation. * South Asian ethnicity (Pakistani, Indian, Bangladeshi, Sri Lankan, or Nepali origin). * First STEMI: ST-elevation ≥1 mm in ≥2 contiguous limb leads, or ≥2 mm in ≥2 contiguous precordial leads, or new LBBB with consistent presentation. * Symptom onset to hospital arrival ≤12 hours. * Scheduled for primary PCI with intent to perform balloon inflation and stenting. * eGFR ≥45 mL/min/1.73m² (CKD-EPI) from point-of-care creatinine at presentation. * Able to take oral medication (or crushed tablet with water), swallowing ability confirmed by treating nurse. * Written informed consent from patient or legally authorised representative Exclusion Criteria: * Cardiogenic shock at presentation (Killip IV: SBP \<90 mmHg despite volume, requiring vasopressors, IABP, or mechanical circulatory support). * Type 1 diabetes mellitus. * SGLT2 inhibitor use within 3 months of presentation. * Active urinary tract infection or genital mycotic infection. * eGFR \<45 mL/min/1.73m² at presentation. * Severe hepatic impairment (Child-Pugh Class C). * Known hypersensitivity to empagliflozin or any SGLT2 inhibitor. * History of diabetic ketoacidosis (euglycaemic or classical) at any time. * Pregnancy, breastfeeding, or refusal of contraception (women of childbearing potential). * Prior myocardial infarction or prior coronary revascularisation. * Left main culprit artery as the infarct-related vessel. * Rescue PCI after fibrinolysis in the current presentation. * Severe multivessel disease with anticipated need for urgent CABG within 48 hours. * Cardiac arrest with coma (GCS \<8) at presentation consent not obtainable and metabolic state unpredictable. * Significant metabolic abnormality precluding oral drug: severe vomiting, nil-by-mouth status, or frank dehydration with SBP \<100 mmHg on arrival. * Concurrent participation in another interventional clinical trial. * Life expectancy \<6 months from a non-cardiac cause. * Expected inability to attend the 90-day follow-up visit.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rehman Medical Institute
Peshawar, Khyber Pakhtun Khwa, 25000, Pakistan
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