Clinical trial NCT06137430: Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
Official title: Effect of Sodium Glucose Cotransporter 2 Inhibitiors on Left Ventricular Remodeling Among Diabetic and Non Diabetic Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: SGLT2 Inhibitiors Remodeling Effect
Chronic Heart Disease
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diabetic and non-diabetic with chronic heart failure patients

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

- The study will enroll outpatients with HF on optimized medical therapy defined by the guidelines of the European Society of Cardiology (ESC) that were used when the study was initiated.

Age ranges from 18 to 75 years

Exclusion Criteria:

* age \<18 and \> 75 years. 2. If there is any contraindication in using SGLT2 inhibitors, patients that had symptomatic hypotension (systolic blood pressure \< 95 mmHg, impaired renal function (eGFR \<30ml/min/1.73m2 calculated by the CKD-EPI formula), Potassium serum levels \> 5.2 mmol/L and Liver dysfunction (defined as hepatic parameters such as ALT, AST and/or ALP elevated ≥3 times above the upper 99th reference percentile.

Primary outcomes:
measure: Left ventricular global longitudinal strain and diastology parameters, including (left atrial volume indexed) LAVI in chronic heart failure patients on SGLT2 inhibitors, comparing diabetic and non-diabetic patients
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
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