Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06137430 |
| Other study ID # |
Effect of SGLT2 inhibitiors |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
Assiut University |
| Contact |
Ahmad Abd eltwab Abd elzaher, GP |
| Phone |
01001806037 |
| Email |
ahmedabdeltwab777[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To evaluate the efficacy of SGLT2 inhibitors on left ventricular global longitudinal strain
and diastology parameters among diabetic and non-diabetic patients with chronic heart failure
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.
