Myocardial Infarction
Conditions
Brief summary
The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.
Detailed description
In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction. Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT. Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.
Interventions
DRUGDapagliflozin
Dapagliflozin 10 mg PO QD
DRUGPlacebo
Placebo
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will receive either Dapagliflozin or Placebo. They will not know which arm they have been allocated to.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction treated within the 24 hours of beginning of symptoms * Signed informed consent * SBP \> 90 mmHg * Age \>= 18 years
Exclusion criteria
* Glomerular Filtration Rate \< 30 ml/min/1.73 m2. * Pregnant or lactating woman * Cancer or life-threatening condition * Use of continuous parental inotropic agents * Psychiatric disease incompatible with being in study. * Any contraindication to MRI procedures. * Any other medical or physical condition considered to be inappropriate by a study physician * Scheduled for a PCI or CABG within the next 6 months * Hemodynamic unstability * Currently on any SGLT2i * One or more episodes of severe hypoglicemia * Acute urinary or genital infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular remodeling | 6 months | Changes in end-diastolic and end-systolic left ventricular volumes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Natriuretic peptides | 6 months | Change in natriuretic peptide |
| Quality of life assessed with KCCQ | 6 months | Change in quality of life |
Countries
Mexico
Contacts
Primary ContactEduardo Almeida-Gutierrez, MD
Outcome results
None listed