Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783870
Status:
RECRUITING
Last Update Posted:
2021-03-05
First Post:
2021-03-02
Brief Title:
Effect of Dapagliflozin on LV Remodeling Post AMI
Sponsor:
Instituto Mexicano del Seguro Social
Organization:
Instituto Mexicano del Seguro Social
Study Overview
Official Title:
Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None