Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2021-03-03
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin 10 mg PO QD
Dapagliflozin
Dapagliflozin 10 mg PO QD
Control
Placebo PO QD
Placebo
Placebo
Interventions
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Dapagliflozin
Dapagliflozin 10 mg PO QD
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* SBP \> 90 mmHg
* Age \>= 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Eduardo Almeida Gutiérrez
MD
Principal Investigators
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Juan B Ivey-Miranda, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Hospital de Cardiología, Centro Médico Nacional Siglo XXI
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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F-2020-3604-035
Identifier Type: -
Identifier Source: org_study_id
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