Dapaglifozin use in patients with heart failure during acute myocardial infarctio

Phase 1

• 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: 20.0Level: LLTClassification code 10064346Term: STEMISystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10011949Term: Decompensation cardiacSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-002813-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Type 2 diabetes mellitus
ST-elevate myocardial infarction
Percutaneous coronary angioplasty <12 hours from symptom onset
TIMI coronary flow 0-1 at the time of primary PCI
Left ventricle ejection fraction 40% assessed within 12 hours from admission
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified