Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619600
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients with a ST-segment Elevation Myocardial Infarction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Dapagliflozin in Myocardial Fibrosis and Ventricular Function in Patients with a ST-segment Elevation Myocardial Infarction
Status:
ACTIVE_NOT_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:
DAPA-STEMI
Brief Summary:
The DAPA-STEMI trial investigates whether dapagliflozin a sodium-glucose cotransporter 2 inhibitor SGLT2i reduces heart muscle scarring fibrosis and improves heart function after a ST-segment elevation myocardial infarction STEMI The trial will use cardiac MRI to measure changes in heart structure and function over six months Patients aged 30-85 who have had a recent STEMI will receive either dapagliflozin or a placebo The study aims to provide mechanistic insights into heart failure prevention after heart attacks
Detailed Description:
The DAPA-STEMI trial is a clinical research study designed to investigate whether dapagliflozin a medication known as a sodium-glucose cotransporter 2 inhibitor SGLT2i can reduce the extent of heart muscle damage and improve heart function in patients who have experienced a heart attack Specifically the study focuses on patients who have had a type of heart attack known as a ST-segment elevation myocardial infarction STEMI which is a serious condition that often leads to long-term heart damage and heart failure
The study aims to answer whether treatment with dapagliflozin can reduce the amount of scarring fibrosis that develops in the heart after a heart attack and whether this reduction in scarring improves the overall function of the heart Scarring in the heart can lead to stiffening of the heart muscle which affects its ability to pump blood effectively and can result in heart failure By using advanced imaging techniques such as cardiac magnetic resonance imaging MRI the study will measure changes in the heart39s structure and function over time
The primary question the study seeks to answer is whether dapagliflozin can decrease the amount of heart muscle scarring fibrosis and improve heart function when compared to a placebo an inactive treatment The study will also examine whether dapagliflozin affects other important heart health markers such as blood levels of proteins that indicate heart muscle damage and the overall size and function of the heart39s chambers
The study will enroll patients aged 30 to 85 who have recently experienced a STEMI and undergone successful treatment to open the blocked artery Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months and their heart function and scarring will be monitored through imaging and blood tests during that time
The results of this study may provide important insights into new ways to protect the heart after a heart attack and prevent the development of heart failure offering potential benefits to a wide range of patients who experience heart attacks
The study aims to answer whether treatment with dapagliflozin can reduce the amount of scarring fibrosis that develops in the heart after a heart attack and whether this reduction in scarring improves the overall function of the heart Scarring in the heart can lead to stiffening of the heart muscle which affects its ability to pump blood effectively and can result in heart failure By using advanced imaging techniques such as cardiac magnetic resonance imaging MRI the study will measure changes in the heart39s structure and function over time
The primary question the study seeks to answer is whether dapagliflozin can decrease the amount of heart muscle scarring fibrosis and improve heart function when compared to a placebo an inactive treatment The study will also examine whether dapagliflozin affects other important heart health markers such as blood levels of proteins that indicate heart muscle damage and the overall size and function of the heart39s chambers
The study will enroll patients aged 30 to 85 who have recently experienced a STEMI and undergone successful treatment to open the blocked artery Participants will be randomly assigned to receive either dapagliflozin or a placebo for six months and their heart function and scarring will be monitored through imaging and blood tests during that time
The results of this study may provide important insights into new ways to protect the heart after a heart attack and prevent the development of heart failure offering potential benefits to a wide range of patients who experience heart attacks
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