Phase 3
N=476
Impact of EMpagliflozin on Cardiac Function and Biomarkers of Heart Failure in Patients With Acute MYocardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03087773 ↗Enrolled (actual)
476
Serious AEs
13.2%
Results posted
Aug 2024
Primary outcome: Primary: Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels — -84.9; -82.2 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Empagliflozin 10 mg (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes of Nt-proBNP (N-terminales Pro Brain Natriuretic Peptide) Levels |
-84.9; -82.2 | — |
| SECONDARY Changes in Ejection Fraction |
4.7; 2.8 | — |
| SECONDARY Changes in Left Ventricular End-diastolic Volume |
3.4; 13.5 | — |
| SECONDARY Duration of Hospital Stay |
6.0; 6.0 | — |
| SECONDARY Changes in E/è Ratio From Baseline to Week 26 |
-9.7; -0.7 | — |
| SECONDARY Changes in Left Ventricular End-systolic Volume (LVESV) From Baselin to Week 26 |
-3.6; 4.3 | — |
Summary
This study is planned to investigate the impact of Empagliflozin on biomarkers of heart failure in patients with myocardial infarction with and without type 2 diabetes mellitus within 6 months after the event.
Eligibility Criteria
Inclusion Criteria
- Myocardial infarction with evidence of significant myocardial necrosis defined as a rise in creatinine kinase >800 U/l and a troponin T-level (or troponin I-level) >10x upper limit of normal (ULN). In addition at least 1 of the following criteria must be the met:
- Symptoms of ischemia
- ECG (electrocardiogram) changes indicative of new ischemia (new ST-T changes or new LBBB)
- Imaging evidence of new regional wall motion abnormality
- 18 - 80 years of age
- Informed consent has to be given in written form
- estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2
- Blood pressure before first drug dosing: Riva Rocci (RR) systolic >110 mmHg
- Blood pressure before first drug dosing: Riva Rocci (RR) diastolic >70 mmHg
- ≤72h after myocardial infarction (after the performance of a coronary angiography)
Exclusion Criteria
- Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
- Blood potential hydrogen (pH) 1 episode of severe hypoglycemia within the last 6 months and treatment with insulin or sulfonylurea
- Females of childbearing potential without adequate contraceptive methods (i.e. sterilization, intrauterine device, vasectomized partner; or medical history of hysterectomy)
- Acute symptomatic urinary tract infection (UTI) or genital infection
- Patients currently being treated with any SGLT-2 inhibitor or having received treatment with any SGLT-2 inhibitor within the 4 weeks prior to the screening visit
Data sourced from ClinicalTrials.gov (NCT03087773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.