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Early use of dapagliflozin in patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 Dapagliflozin trial
EU CTIS ID: 2025-521481-10-00
What this study is testing
The aim will be to study the potential cardioprotective effects (primarily the reduction of the infarct size) of an early use of the SGLT-2 inhibitor, to evaluate its safety (occurrence of a composite event including cardiovascular death, worsening of heart failure during hospitalization, myocardial re-infarction, stroke, or unplanned coronary revascularization) and side effects
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥18 years
- STEMI regardless of the involved epicardial territories
- Primary PCI <12 hours from symptom onset
- TIMI coronary flow 0-1 at the time of primary PCI
- Imaging evidence of new regional wall motion abnormality and LVEF ≤40% by ventriculography performed at the time of primary PCI or by trans-thoracic echocardiography performed as soon as possible within 12 hours from admission
- Written informed consent to participate the study
You likely can't join if
- Cardiogenic shock on admission
- Pregnancy or breastfeeding. For women of childbearing potential, any pregnancy status must be ascertained with a pregnancy test during the screening or randomization visit
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or in the 5 half-lives of the study drug, whichever is longer
- Symptomatic hypotension or blood pressure <90 mmHg
- History of restrictive cardiomyopathy, constrictive pericarditis, hypertrophic cardiomyopathy or untreated severe heart valve disease
- History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes
See the full eligibility criteria
- Age ≥18 years
- STEMI regardless of the involved epicardial territories
- Primary PCI <12 hours from symptom onset
- TIMI coronary flow 0-1 at the time of primary PCI
- Imaging evidence of new regional wall motion abnormality and LVEF ≤40% by ventriculography performed at the time of primary PCI or by trans-thoracic echocardiography performed as soon as possible within 12 hours from admission
- Written informed consent to participate the study
- Cardiogenic shock on admission
- Pregnancy or breastfeeding. For women of childbearing potential, any pregnancy status must be ascertained with a pregnancy test during the screening or randomization visit
- Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or in the 5 half-lives of the study drug, whichever is longer
- Symptomatic hypotension or blood pressure <90 mmHg
- History of restrictive cardiomyopathy, constrictive pericarditis, hypertrophic cardiomyopathy or untreated severe heart valve disease
- History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes
- History of heart failure with NYHA IV
- Severe hepatic insufficiency
- Active cancer
- eGFR<30 ml/min
- Hypersensitivity to the active substance or to any of the excipients
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.