Dapaglifozin use in patients with heart failure during acute myocardial infarction

Early use of dapaglifozin in diabetic patients with acute myocardial infarction and reduced ejection fraction: the randomized ARMYDA-9 DAPA trial - ARMYDA-9 DAPA trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002813-33-IT

Enrollment

140

Registered

2022-01-27

Start date

2023-02-21

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 2 diabetes and ST-elevation myocardial infarction treated with primary primary percutaneous coronary intervention and reduced left ventricle ejection fraction. MedDRA version: 20.0 Level: LLT Classification code 10064346 Term: STEMI System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10011949 Term: Decompensation cardiac System Organ Class: 100000004849

Interventions

Trade Name: FORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 28 COMPRESSE Product Name: FORXIGA Product Code: [A10BX09] Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 2 diabetes mellitus ST-elevate myocardial infarction Percutaneous coronary angioplasty =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: Cardiogenic shock Symptomatic hypotension History of restrictive cardiomyopathy, constrictive pericarditis, or untreated severe heart valve disease History of diabetic ketoacidosis, secondary diabetes or type 1 diabetes Severe hepatic insufficiency Active cancer eGFR<30 ml/min

Design outcomes

Primary

Measure	Time frame
Main Objective: We investigate te effect of an early use of the SGLT-2 inhibitor dapaglifozin in term of infarct size reduction (assessed by cardiac MRI) in diabetic patients admitted for ST-elevation myocardial infarction with low left ventricle ejection fraction.;Secondary Objective: We will investigate potential cardioprotective effects of SGLT-2 inhibitor and to evaluate its safety;Primary end point(s): Infarct size, as assessed by cardiac MRI;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: We investigate te effect of an early use of the SGLT-2 inhibitor dapaglifozin in term of infarct size reduction (assessed by cardiac MRI) in diabetic patients admitted for ST-elevation myocardial infarction with low left ventricle ejection fraction.;Secondary Objective: We will investigate potential cardioprotective effects of SGLT-2 inhibitor and to evaluate its safety;Primary end point(s): Infarct size, as assessed by cardiac MRI;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): Difference in the change of body weight; cardiovascular death or worsening heart failure; re-myocardial infarction, stroke or unplanned coronary revascularization; All-cause death; Duration of in-hospital stay; Arterial pressure values; Side effects; Cardiac features at MRI and echocardiography; Laboratory outcomes differences (B-type natriuretic peptide, Renal function, EPO, hematocrit);Timepoint(s) of evaluation of this end point: 3 months; 3 months; 3 months; 3 months; Discharge; Discharge and 3 months; 3 months; Baseline and 3 months; Baseline and 3 months	—

Measure

Time frame

Secondary end point(s): Difference in the change of body weight; cardiovascular death or worsening heart failure; re-myocardial infarction, stroke or unplanned coronary revascularization; All-cause death; Duration of in-hospital stay; Arterial pressure values; Side effects; Cardiac features at MRI and echocardiography; Laboratory outcomes differences (B-type natriuretic peptide, Renal function, EPO, hematocrit);Timepoint(s) of evaluation of this end point: 3 months; 3 months; 3 months; 3 months; Discharge; Discharge and 3 months; 3 months; Baseline and 3 months; Baseline and 3 months

—

Countries

Italy

Contacts

Public ContactMarco Mennuni - SC Cardiologia

AOU Maggiore della Carità di Novara

marcog.mennuni@maggioreosp.novara.it3292410740

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026