Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2025-12-17 @ 5:04 AM
Study NCT ID:
NCT06137430
Status:
None
Last Update Posted:
2023-11-18 00:00:00
First Post:
2023-11-14 00:00:00
Brief Title:
Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
Status:
None
Status Verified Date:
2023-11
Last Known Status:
NOT_YET_RECRUITING
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:
Sodium-glucose cotransporter 2 inhibitors (SGLT2i) have an established place in the therapy of heart failure (HF), as they have been shown to significantly reduce all-cause mortality, cardiovascular mortality, and hospitalizations in HFrEF patients, regardless of the presence of diabetes mellitus.
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental HF therapy.
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes.
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression, and current well-established HF phenotypes are based on LVEF. However, other relevant players, such as the left atrium, have received less attention. Indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (LV) filling during diastole. Additionally, atrial dysfunction can directly lead to pulmonary congestion. Left atrial (LA) remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF. SGLT2 inhibition has been associated with reduced left ventricular (LV) and left atrial volumes in HF; however, its relationship with contemporary echocardiographic parameters of global LV systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated.
Measuring the effect of SGLT2i therapy on left ventricular systolic function (LV) has previously been assessed by changes in heart size volume and ejection fraction.
In current clinical practice, the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction (LVEF), which remains the gold standard despite some notable limitations.
In the last decade, LV global longitudinal strain (GLS) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical LV systolic dysfunction.
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular, molecular, vascular, interstitial, and electrical effects justifies its role as fundamental HF therapy.
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes.
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression, and current well-established HF phenotypes are based on LVEF. However, other relevant players, such as the left atrium, have received less attention. Indeed, the left atrium plays a critical role in cardiac function, particularly in left ventricular (LV) filling during diastole. Additionally, atrial dysfunction can directly lead to pulmonary congestion. Left atrial (LA) remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF. SGLT2 inhibition has been associated with reduced left ventricular (LV) and left atrial volumes in HF; however, its relationship with contemporary echocardiographic parameters of global LV systolic function, including global longitudinal strain and myocardial work, has not been thoroughly investigated.
Measuring the effect of SGLT2i therapy on left ventricular systolic function (LV) has previously been assessed by changes in heart size volume and ejection fraction.
In current clinical practice, the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction (LVEF), which remains the gold standard despite some notable limitations.
In the last decade, LV global longitudinal strain (GLS) has emerged as a more accurate predictor of poor outcomes, revealing subtle abnormalities and preclinical LV systolic dysfunction.
Detailed Description:
Sodium-glucose cotransporter 2 inhibitors SGLT2i have an established place in the therapy of heart failure HF as they have been shown to significantly reduce all-cause mortality cardiovascular mortality and hospitalizations in HFrEF patients regardless of the presence of diabetes mellitus
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular molecular vascular interstitial and electrical effects justifies its role as fundamental HF therapy
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression and current well-established HF phenotypes are based on LVEF However other relevant players such as the left atrium have received less attention Indeed the left atrium plays a critical role in cardiac function particularly in left ventricular LV filling during diastole Additionally atrial dysfunction can directly lead to pulmonary congestion Left atrial LA remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF SGLT2 inhibition has been associated with reduced left ventricular LV and left atrial volumes in HF however its relationship with contemporary echocardiographic parameters of global LV systolic function including global longitudinal strain and myocardial work has not been thoroughly investigated
Measuring the effect of SGLT2i therapy on left ventricular systolic function LV has previously been assessed by changes in heart size volume and ejection fraction
In current clinical practice the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction LVEF which remains the gold standard despite some notable limitations
In the last decade LV global longitudinal strain GLS has emerged as a more accurate predictor of poor outcomes revealing subtle abnormalities and preclinical LV systolic dysfunction
The growing evidence of the effect of SGLT2i on cardiac remodeling through cellular molecular vascular interstitial and electrical effects justifies its role as fundamental HF therapy
SGLT2 inhibition in heart failure promotes reverse cardiac remodeling and is associated with better clinical outcomes
Adverse myocardial remodeling affecting the left ventricle is a key factor in HF progression and current well-established HF phenotypes are based on LVEF However other relevant players such as the left atrium have received less attention Indeed the left atrium plays a critical role in cardiac function particularly in left ventricular LV filling during diastole Additionally atrial dysfunction can directly lead to pulmonary congestion Left atrial LA remodeling occurs in HF irrespective of the degree of LV systolic dysfunction and can be observed in the presence of preserved or reduced LVEF SGLT2 inhibition has been associated with reduced left ventricular LV and left atrial volumes in HF however its relationship with contemporary echocardiographic parameters of global LV systolic function including global longitudinal strain and myocardial work has not been thoroughly investigated
Measuring the effect of SGLT2i therapy on left ventricular systolic function LV has previously been assessed by changes in heart size volume and ejection fraction
In current clinical practice the assessment of LV systolic function is still mainly based on the measurement of LV ejection fraction LVEF which remains the gold standard despite some notable limitations
In the last decade LV global longitudinal strain GLS has emerged as a more accurate predictor of poor outcomes revealing subtle abnormalities and preclinical LV systolic dysfunction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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