Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615674
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Effect of Dapagliflozin Administration on the Apoptosis Levels of Patients With Acute Myocardial Infarction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Dapagliflozin on the Apoptosis Levels of Patients With Acute Myocardial Infarction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The currently known Sodium-Glucose Transporter 2 SGLT-2 inhibitors are recognized not only for their effects on improving intravascular glucose levels but also for their cardioprotective effects including improvements in endothelial dysfunction inhibition of platelet activation reduction in autophagy processes oxidative stress and inflammation as well as inhibition of the NaH exchanger pathway which potentially reduces cell damage and death resulting from ischemia and reperfusion processes Research on the benefits of SGLT-2 inhibitors in pre-clinical studies with myocardial infarction has shown a significant reduction in myocardial apoptosis indicated by reduced levels of caspase-3 and the apoptosis index Additionally there was an increase in ketone bodies and myocardial ATP reduced levels of inflammatory cytokines free radicals and infarct area as well as improvements in left ventricular ejection fraction However large-scale studies in humans have thus far been limited to investigating the effects of SGLT-2 inhibitors on mortality rehospitalization rates due to heart failure cardiometabolic factors and improvements in remodeling parameters in myocardial infarction patients with the use of empagliflozin or dapagliflozin Based on literature reviews there have been no studies to date that directly demonstrate the effects of dapagliflozin on apoptosis caspase-3 levels in myocardial infarction patients
Detailed Description:
The study is a randomized controlled trial single-center study in Acute Myocardial Infarction AMI patients held in Moewardi General Hospital Central Java Indonesia The investigator divided 40 patients with AMI into two groups the first is the Dapagliflozin group which will get 10mg of Dapagliflozin once a day every morning and the second group will have a placebo once a day every morning also for 14 days Each patient will be checked for Caspase-3 level from blood serum as primary outcome and Global Work GW echocardiographic parameters such as GWI GCW GWW and GWE as secondary outcome at admission and 14 days after intervention The study was approved by the hospital ethics committee The clinical parameters above will then be analyzed To determine the mean difference between each group intervention and control before and after treatment a paired T-test is used if the data distribution is normal if not the Wilcoxon test is used To determine the mean difference between unpaired groups treatment and control an independent T-test is used if the distribution is normal if not the Mann-Whitney test is used Normality testing is performed using the Shapiro-Wilk test considering the sample size is less than 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None